Prescription medicine

Orphenadrine First approved as Disipal

Orphenadrine (Disipal) is a prescription medicine with an FDA approval on record since 1957. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.454 per orphenadrine ER 100 mg tablet in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the orphenadrine FDA label on DailyMed (effective September 10, 2025, Lupin Pharmaceuticals, Inc.); the NDA 10653 record on Drugs@FDA; every orphenadrine label on DailyMed.

Highlights of the record

FDA label of September 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Forms and strengths

100 mg
30 mg/ml
60 mg/2ml

Extended-release tablet; injection; injection (solution).

On the market

Earliest approval on file: May 10, 1957 Disipal, 3M; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 10 first July 16, 1981; 8 with a marketed status in Drugs@FDA
Labelers listed (NDC): 17 of which 17 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $0.454 per tablet Orphenadrine ER 100 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 3 since 2013 0 Class I among all firms' recalls; latest March 21, 2022
FAERS reports: 621 through July 30, 2026

What is orphenadrine used for?

From the label: indications and usage
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Conditions named in the indications of orphenadrine's FDA labels, with every medicine labeled for each:

Muscle spasms and spasticity

From other orphenadrine labels
Muscle spasms and spasticity: INDICATIONS AND USAGE Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

FDA pharmacologic class: Muscle Relaxant.

Source: FDA drug label (ORPHENADRINE CITRATE), Lupin Pharmaceuticals, Inc., effective September 10, 2025 (SPL set 7b76c8a7-dd0c-481c-8299-26dfd38ce066), via openFDA; the full label on DailyMed

Is there a generic for orphenadrine (Disipal)?

The FDA approved the first generic orphenadrine on July 16, 1981. 10 generic applications are approved; 8 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 orphenadrine from 17 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1957 earliest approval on file
1981 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for orphenadrine (Disipal)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.454 per Orphenadrine ER 100 mg tablet, up 6% from $0.429 on October 8, 2025. 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.

Orphenadrine ER 100 mg tablet (generic)

$0.482

$0.389

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Orphenadrine 60 mg/2 mL vial	Generic	$6.40 per mL	$12.80 per vial	+11%
Orphenadrine ER 100 mg tablet	Generic	$0.454 per tablet	$13.61	+6%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has orphenadrine been recalled?

The FDA's Enforcement Report lists 3 recalls naming orphenadrine since 2013: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
March 21, 2022	Class II	Sandoz, Inc	CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
July 11, 2014	Class III	Sandoz Inc	Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
July 2, 2013	Class II	Aidapak Services, LLC	Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for orphenadrine?

The FDA Adverse Event Reporting System holds 621 reports that list orphenadrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 65 are coded as a death and 173 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

Pain65
Nausea (named in the label)52
Fatigue48
Anxiety (named in the label)46
Drug Ineffective (a use or a product term, not a reaction)45
Arthralgia41
Headache (named in the label)41
Dizziness (named in the label)37

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as orphenadrine?

8 other medicines are given the same way (oral) and in the same FDA class as orphenadrine or labeled mainly for the same use (muscle spasms and spasticity), the same class first. Muscle spasms and spasticity lists all 12 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 (oral)	Pharmacy cost	Shortage
Cyclobenzaprine	Muscle spasms and spasticity	60 labelers	$0.0171 per tablet 10 mg tablet	No current entry
Methocarbamol	Muscle spasms and spasticity	54 labelers	$0.0395 per tablet 500 mg tablet	No current entry
Metaxalone	Muscle spasms and spasticity	33 labelers	$0.452 per tablet 800 mg tablet	No current entry
Carisoprodol	Muscle spasms and spasticity	24 labelers	$0.0706 per tablet 350 mg tablet	No current entry
Chlorzoxazone	Muscle spasms and spasticity	19 labelers	$0.210 per tablet 500 mg tablet	No current entry
Baclofen	Muscle spasms and spasticity	52 labelers	$0.032 per tablet 10 mg tablet	No current entry
Tizanidine	Muscle spasms and spasticity	51 labelers	$0.0331 per tablet 4 mg tablet	No current entry
Dantrolene	Muscle spasms and spasticity	7 labelers	$0.409 per capsule 25 mg capsule	No current entry

Every medicine labeled for the same conditions as orphenadrine

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does orphenadrine compare with medicines for the same use?

7 side-by-side pages set orphenadrine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to orphenadrine: 8 medicines for the same use
Other muscle relaxants: the pharmacologic class, with prices and generics
Orphenadrine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other