Orphenadrine citrate 60 mg/2mL Injection — NDC 0641-6182-25 (Billing 00641-6182-25)
This is a package of Orphenadrine citrate 60 mg/2mL Injection from Hikma Pharmaceuticals USA Inc., marketed since Apr 2003 and currently FDA-listed; retail pharmacies pay about $7.07 per mL (NADAC).
NDC database record
One package, one record: these facts belong to NDC 0641-6182-25 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0641 labeler · 6182 product · 25 package
- Package marketed since
- Apr 28, 2003
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0641618225 6
- Medicaid fills, this package
- 6,557 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004593
- GCN: 17653
- GPI-14 (Medi-Span): 75100080102005
- HICL (First Databank): 001906
- AHFS class code: 12:20.10.00
- RxCUI (RxNorm): 994541
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Muscle Relaxant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It's a common assumption, but orphenadrine actually doesn't directly relax tense muscles. Researchers believe its benefit comes from pain-relieving properties — so it helps you fee...
- What exactly does orphenadrine do — does it just relax my muscles?
- Take one extended-release tablet in the morning and one in the evening — that's twice a day. Try to stick to the same times each day. If you're unsure whether to take it with food...
- How should I take the extended-release tablet?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.074 | $3,537.20 / 500 ml |
| Medicaid paysCMS SDUD · 12 mo | $8.29 | $4,143.60 / 500 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2360 | $7.777 / J2360 unit | — |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00641-6182-10 0641-6182-10 Main listing | 10 VIAL in 1 BOX / 2 mL in 1 VIAL | $5.73 / mL | $114.61 | 2003-04-28 | — | Active |
| 00641-6182-25 You're viewing this | 25 BOX in 1 BOX / 10 VIAL in 1 BOX / 2 mL in 1 VIAL | $7.07 / mL | $3,537.20 | 2003-04-28 | — | Active |
Per mL, this pack runs about 23% above the cheapest pack (NDC 00641-6182-10, $5.73 vs $7.07 NADAC).
This pack accounts for about 37% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Orphenadrine citrate 60 mg/2mL Injection?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Orphenadrine Citrate 30 mg/mL 25021-0651-02 | Sagent | 10 vials | $5.730 | AP | Availability likely | save 19% |
| Orphenadrine citrate 60 mg/2mLthis 00641-6182-25 | Hikma | 10 vials | $7.074 | AP | Availability likely | — |
| Orphenadrine Citrate 30 mg/mL 00591-3222-47 | Actavis | 10 ampules | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Orphenadrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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5.8 mg / 2 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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2 mg / 2 mL
UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Hikma Pharmaceuticals USA Inc. labeler code 00641
- Dicyclomine Hydrochloride 10 mg/mL Injection NDC 0641-6173-10
- Octreotide Acetate 50 ug/mL Injection, Solution NDC 0641-6174-10
- Octreotide Acetate 100 ug/mL Injection, Solution NDC 0641-6175-10
- Octreotide Acetate 500 ug/mL Injection, Solution NDC 0641-6176-10
- Octreotide Acetate 200 ug/mL Injection, Solution NDC 0641-6177-01
- Octreotide Acetate 1000 ug/mL Injection, Solution NDC 0641-6178-01
- Digoxin .25 mg/mL Injection NDC 0641-6184-25
- Phenylephrine Hydrochloride 10 mg/mL Injection NDC 0641-6188-10
- Phenylephrine Hydrochloride 10 mg/mL Injection NDC 0641-6189-10
- Midazolam 5 mg/mL Injection NDC 0641-6190-10
- Morphine Sulfate 2 mg/mL Injection NDC 0641-6191-10
- Morphine Sulfate 4 mg/mL Injection NDC 0641-6192-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Adults - One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours. Relief may be maintained by one (100 mg) orphenadrine citrate tablet twice daily. Parenteral drug products should be inspected visually for particulate matter, whenever solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia gravis. Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.
⚠️ Warnings ▾
WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine citrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly. Orphenadrine citrate injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses.
Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported.
No causal relationship has been established. Rare instances of anaphylactic reaction have been reported associated with the intramuscular injection of orphenadrine citrate.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine. It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children have not been established; therefore, this drug is not recommended for use in the pediatric age group.
🆘 Overdosage ▾
OVERDOSAGE Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable. Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anticholinergic actions.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Orphenadrine Citrate Injection, USP is supplied as follows: Cartons of 10 ( NDC 0641-6182-10 ) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution. Cartons of 25 ( NDC 0641-6182-25 ) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from light. Single dose vial. Discard unused portion.
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922 Revised May 2023 462-734-02
📋 Description ▾
DESCRIPTION Orphenadrine citrate is the citrate salt of orphenadrine (±)- N , N -dimethyl-2-[( o -methyl-α-phenylbenzyl)oxy]-ethylamine citrate (1:1). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.
Each vial contains 60 mg of orphenadrine citrate in aqueous solution. Each vial also contains: sodium metabisulfite, 2 mg; sodium chloride, 5.8 mg; sodium hydroxide, to adjust pH; and water for injection, q.s. to 2 mL. The structural formula is: C 18 H 23 NO•C 6 H 8 O 7 MW 461.50 Structural Formula
⚠️ Precautions ▾
PRECAUTIONS Confusion, anxiety and tremors have been reported in few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases. Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias.
Safety of continuous long-term therapy with orphenadrine has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended. Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine.
It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in children have not been established; therefore, this drug is not recommended for use in the pediatric age group.
🔒 Drug Abuse and Dependence ▾
DRUG ABUSE AND DEPENDENCE Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - CONTAINER NDC 0641- 6182 -01 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For IV or IM use Discard unused portion 2 mL Single Dose Vial vial
PRINCIPAL DISPLAY PANEL -SHELF PACK NDC 0641- 6182 -10 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For Intravenous or Intramuscular use 10 x 2 mL Single Dose Vials NDC 0641- 6182 -25 Rx only Orphenadrine Citrate Injection, USP 60 mg per 2 mL (30 mg/mL) For Intravenous or Intramuscular use 25 x 2 mL Single Dose Vials sp 25 pack label