Prescription drug · ANDA
Orphenadrine Citrate NDC 0591-3222
Orphenadrine citrate 30 mg/mL · Injection · Intramuscular, Intravenous · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3222-47 | 0059132224700591322247 | 10 AMPULE in 1 CARTON (0591-3222-47) / 2 mL in 1 AMPULE (0591-3222-02)Marketed from Jul 8, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Orphenadrine Citrate
- Generic name (nonproprietary)
- orphenadrine citrate
- Active ingredients
- Orphenadrine citrate — 30 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084779
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 0591-3222_76bd2057-e1ac-4529-9663-f6139218eeabSPL ID 76bd2057-e1ac-4529-9663-f6139218eeabSPL set ID aec8ad3a-f717-4e74-b7b9-19debdaad79aRxCUI 994541UNII X0A40N8I4S
- Pharmacologic class
- Muscle Relaxant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400591322247followed by a unit qualifier and the quantityPackage 00591-3222-47. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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 musculo-skeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.
Excerpt only. Read the full label for complete information.
About NDC 0591-3222
- What is NDC 0591-3222?
- 0591-3222 is the product NDC for Orphenadrine Citrate, Orphenadrine citrate 30 mg/mL injection, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orphenadrine Citrate.
- What is the active ingredient?
- Orphenadrine citrate.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orphenadrine Citrate?
- 18 other product NDCs are listed under this name. See all Orphenadrine Citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orphenadrine Citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4506 | 70518-4506-0070518-4506-0170518-4506-02+1 more |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-040 | 82868-0040-14 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0340 | 80425-0340-0180425-0340-02 |
| Orphenadrine Citrate | Orphenadrine citrate 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-651 | 25021-0651-02 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Lake Erie Medical DBA Quality Care Products LLC | 49999-046 | 49999-0046-60 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-810 | 60760-0810-30 |
| Orphenadrine citrate | Orphenadrine citrate 60 mg/2mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6182 | 00641-6182-25 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Sandoz Inc | 0185-0022 | 00185-0022-01 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-632 | 63187-0632-3063187-0632-6063187-0632-90 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | RedPharm Drug | 67296-1077 | 67296-1077-01 |