Prescription medicine
Betamethasone Brand names: Celestone, Sernivo, Diprolene
Betamethasone (Celestone) is a prescription medicine with an FDA approval on record since 1961. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.418 per gram (Betamethasone dp 0.05% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the betamethasone FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the NDA 12657 record on Drugs@FDA; every betamethasone label on DailyMed.
Highlights of the record
FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTopical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Forms and strengths
- 0.5 mg/g
- 0.5 mg/ml
- 1 mg/g
- 1 mg/ml
- 1.2 mg/g
- 3 mg/ml / 3 mg/ml
Cream; ointment; ointment (augmented); injection (suspension); cream (augmented).
On the market
- Earliest approval on file
- April 17, 1961 Celestone, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 59 first January 30, 1979; 35 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 34 of which 28 under generic applications, 10 under brand applications, repackagers included
- Last listed patent
- November 19, 2045 Sernivo spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.418 per gram Betamethasone dp 0.05% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 13 since 2012 0 Class I among all firms' recalls; latest April 21, 2022; 15 more by firms not listed as its makers
- FAERS reports
- 10,812 through July 30, 2026
What is betamethasone used for?
From the label: indications and usageTopical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Conditions named in the indications of betamethasone's FDA labels, with every medicine labeled for each:
From other betamethasone labelsAsthma and Eczema (atopic dermatitis): Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal …
Anemia: Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.
Leukemia, lymphoma and myeloma: Neoplastic Diseases For palliative management of leukemias and lymphomas.
Multiple sclerosis: Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
Psoriasis: SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Betamethasone Valerate), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set 0b386ccc-a2d4-4d18-a2d7-e46ff894c674), via openFDA; the full label on DailyMed
Is there a generic for betamethasone (Celestone)?
The FDA approved the first generic betamethasone on January 30, 1979. 59 generic applications are approved; 35 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists betamethasone from 28 labelers under a generic (ANDA) application and from 10 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Celestone Soluspan injection; a patent listed only for Sernivo spray runs to November 19, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1961 earliest approval on file
- 1979 first generic approved
- 2045 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for betamethasone (Celestone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.418 per gram (Betamethasone dp 0.05% cream), down 23% from $0.540 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Betamethasone dp 0.05% cream (generic)
- Celestone soluspan 30 mg/5 mL (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Betamethasone dp 0.05% cream | Generic | $0.418 per gram | n/a | -23% |
| Betamethasone dp 0.05% lot | Generic | $0.292 per mL | n/a | -10% |
| Betamethasone dp 0.05% ointment | Generic | $0.405 per gram | n/a | -30% |
| Betamethasone dp aug 0.05% cream | Generic | $0.167 per gram | n/a | -2% |
| Betamethasone dp aug 0.05% gel | Generic | $2.42 per gram | n/a | +28% |
| Betamethasone dp aug 0.05% lot | Generic | $0.501 per mL | n/a | -14% |
| Betamethasone dp aug 0.05% oin | Generic | $0.588 per gram | n/a | -31% |
| Betamethasone sp-ac 30 mg/5 mL | Generic | $9.14 per mL | n/a | -4% |
| Betamethasone va 0.1% cream | Generic | $0.381 per gram | n/a | -10% |
| Betamethasone va 0.1% lotion | Generic | $0.452 per mL | n/a | -3% |
| Betamethasone valer 0.1% ointm | Generic | $0.553 per gram | n/a | -6% |
| Betamethasone valer 0.12% foam | Generic | $0.652 per gram | n/a | -10% |
| Celestone soluspan 30 mg/5 mL | Brand | $8.87 per mL | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has betamethasone been recalled?
The FDA's Enforcement Report lists 28 recalls naming betamethasone since 2012: 0 Class I (the most serious), 24 Class II, 4 Class III; 2 still ongoing. 15 of them are by firms that FDA's NDC Directory does not list as a maker of betamethasone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 21, 2022 | Class II | McKesson Corporation dba McKesson Drug Company | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study … |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| March 15, 2022 | Class II | Teligent Pharma, Inc. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| August 23, 2021 | Class II | Teligent Pharma, Inc. | Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through … |
| August 13, 2021 | Class II | Akorn, Inc. | Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. |
| February 2, 2021 | Class III | Teligent Pharma, Inc. | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical | Lack of Assurance of Sterility |
| May 20, 2019 | Class III | Teligent Pharma, Inc. | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the betamethasone label say about other medicines?
The betamethasone label names no other medicine on this site. The labels of 10 other medicines name betamethasone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name betamethasone
Source: FDA drug label (Betamethasone Valerate), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set 0b386ccc-a2d4-4d18-a2d7-e46ff894c674), via openFDA; the full label on DailyMed
What do FAERS reports show for betamethasone?
The FDA Adverse Event Reporting System holds 10,812 reports that list betamethasone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 730 are coded as a death and 3,086 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as betamethasone?
5 other medicines are given the same way (topical) and in the same FDA class as betamethasone or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clobetasol | Psoriasis | 40 labelers | $0.126 per gram 0.05% ointment | No current entry |
| Fluocinolone | Psoriasis | 15 labelers | $0.171 per mL 0.01% scalp oil | No current entry |
| Desoximetasone | Psoriasis | 13 labelers | $0.369 per gram 0.25% ointment | No current entry |
| Halobetasol | Psoriasis | 6 labelers | $0.620 per gram 0.05% ointmnt | No current entry |
| Halobetasol and tazarotene | Psoriasis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as betamethasone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does betamethasone compare with medicines for the same use?
8 side-by-side pages set betamethasone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to betamethasone
- 5 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Betamethasone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other