Prescription drug · ANDA
Norgesic NDC 61825-305
orphenadrine citrate, aspirin and caffeine · Orphenadrine citrate 25 mg/1 + 2 more ingredients · Tablet · Oral · Galt Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61825-305-60 | 61825030560 | 60 TABLET in 1 BOTTLE, PLASTIC (61825-305-60)Marketed from May 16, 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)
- Norgesic
- 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
- Galt Pharmaceuticals, LLC
- 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 61825-305_47da9e12-c9c2-d80e-e063-6294a90a86aaSPL ID 47da9e12-c9c2-d80e-e063-6294a90a86aaSPL set ID be2761bc-e537-4039-846a-2ffa3d8b2afcRxCUI 994528, 994530UNII X0A40N8I4S, R16CO5Y76E, 3G6A5W338E
- 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
N461825030560followed by a unit qualifier and the quantityPackage 61825-0305-60. 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 Norgesic TM (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. Norgesic TM Tablets do not directly relax tense muscles in man.
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| 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 25 mg/1 + 2 more ingredients | TabletOral | Atland Pharmaceuticals, LLC | 71993-304 |
| 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 |