Prescription drug · ANDA
Orphenadrine Citrate, Aspirin and Caffeine NDC 71993-304
Orphenadrine citrate 25 mg/1 + 2 more ingredients · Tablet · Oral · Atland Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71993-304-60 | 7199303046071993030460 | 60 TABLET in 1 BOTTLE, PLASTIC (71993-304-60)Marketed from Mar 18, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Aspirin and Caffeine
- Generic name (nonproprietary)
- orphenadrine citrate, aspirin and caffeine
- Active ingredients
- Orphenadrine citrate — 25 mg/1Aspirin — 385 mg/1Caffeine — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Atland Pharmaceuticals, LLCNDC labeler code 71993
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075141
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Centrally-mediated Muscle Relaxation (Physiologic effect)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 71993-304_414d35d9-b9a2-d717-e063-6294a90a9415SPL ID 414d35d9-b9a2-d717-e063-6294a90a9415SPL set ID 61ca2af1-081c-411c-90ce-ec6d9e3157b2RxCUI 994528UNII X0A40N8I4S, R16CO5Y76E, 3G6A5W338EUPC 0371993304605
- Pharmacologic class
- Central Nervous System Stimulant; Methylxanthine; Muscle Relaxant; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471993030460followed by a unit qualifier and the quantityPackage 71993-0304-60. 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 & USAGE Orphenadrine Citrate, Aspirin and Caffeine 25 mg/ 385 mg/ 30 mg Tablets are indicated in: Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin and Caffeine Tablets do not directly relax tense muscles in man.
Excerpt only. Read the full label for complete information.
About NDC 71993-304
- What is NDC 71993-304?
- 71993-304 is the product NDC for Orphenadrine Citrate, Aspirin and Caffeine, Orphenadrine citrate 25 mg/1 + 2 more ingredients tablet, listed with the FDA by Atland Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orphenadrine Citrate, Aspirin and Caffeine.
- What is the active ingredient?
- Orphenadrine citrate, Aspirin, Caffeine.
- Who is the labeler?
- Atland Pharmaceuticals, LLC, NDC labeler code 71993. 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, Aspirin and Caffeine?
- 1 other product NDC are listed under this name. See all Orphenadrine Citrate, Aspirin and Caffeine 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, Aspirin and Caffeine 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, Aspirin and Caffeine | Orphenadrine citrate 50 mg/1 + 2 more ingredients | TabletOral | Atland Pharmaceuticals, LLC | 71993-307 | 71993-0307-60 |
Other NDCs under ANDA 075141
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Norgesicorphenadrine citrate, aspirin and caffeine | Orphenadrine citrate 25 mg/1 + 2 more ingredients | TabletOral | Galt Pharmaceuticals, LLC | 61825-305 |
| Norgesic Forteorphenadrine citrate, aspirin and caffeine | Orphenadrine citrate 50 mg/1 + 2 more ingredients | Tablet, MultilayerOral | Poly Pharmaceuticals, Inc. | 50991-999 |
| Orphenadrine Citrate, Aspirin and Caffeine | Orphenadrine citrate 50 mg/1 + 2 more ingredients | TabletOral | Atland Pharmaceuticals, LLC | 71993-307 |
| Orphengesic Forteorphenadrine citrate, aspirin and caffeine | Orphenadrine citrate 50 mg/1 + 2 more ingredients | TabletOral | Galt Pharmaceuticals, LLC | 61825-302 |