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.NDC labeler code 85534
- 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.
About NDC 85534-0054
- What is NDC 85534-0054?
- 85534-0054 is the product NDC for Gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by HAWAII REPACK, INC..
- What drug is associated with this NDC?
- Gabapentin.
- What is the active ingredient?
- Gabapentin.
- Who is the labeler?
- HAWAII REPACK, INC., NDC labeler code 85534. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gabapentin?
- 561 other product NDCs are listed under this name. See all Gabapentin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gabapentin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-943 | 60760-0943-3060760-0943-90 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4763 | 70518-4763-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0581 | 55154-0581-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0595 | 80425-0595-0180425-0595-0280425-0595-03+1 more |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4746 | 70518-4746-0070518-4746-0170518-4746-02+1 more |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 | 70518-4742-0070518-4742-02 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4740 | 70518-4740-0070518-4740-01 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0580 | 55154-0580-00 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1233 | 67046-1233-03 |
| Gabapentin | Gabapentin 200 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-231 | 73352-0231-01 |
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 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0182 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8486 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8487 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8488 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7674 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7672 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7673 |
| Relgaabigabapentin | Gabapentin 300 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-233 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-532 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7675 |
| Relgaabigabapentin | Gabapentin 200 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-231 |
| Relgaabigabapentin | Gabapentin 400 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-234 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8489 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2970 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-808 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8485 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8484 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-421 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-259 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8816 |
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