Prescription drug · ANDA
Gabapentin NDC 85534-0054
Gabapentin 400 mg/1 · Capsule · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Gabapentin
- Generic name (nonproprietary)
- gabapentin
- Active ingredients
- Gabapentin — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204989
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 85534-0054_559e72cb-a7f3-e1ed-e063-6294a90ad90aSPL ID 559e72cb-a7f3-e1ed-e063-6294a90ad90aSPL set ID dd7adad2-e2f5-4b43-90a4-522bce0be5b3RxCUI 310430, 310431, 310432UNII 6CW7F3G59X
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Gabapentin is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is indicated for: Postherpetic neuralgia in adults ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204989
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 |
|---|---|---|---|---|
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-638 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Direct_Rx | 72189-392 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2970 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0182 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8489 |
| Relgaabigabapentin | Gabapentin 200 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-231 |
| Relgaabigabapentin | Gabapentin 300 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-233 |
| Relgaabigabapentin | Gabapentin 400 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-234 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-289 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8485 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8484 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8488 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Medsource Pharmaceuticals | 45865-194 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8486 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8487 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-259 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3140 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-741 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7672 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7673 |
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