Prescription drug · ANDA
Gabapentin NDC 85534-0010
Gabapentin 800 mg/1 · Tablet · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0010-0 | 85534001000 | 30 TABLET in 1 BOTTLE (85534-0010-0)Marketed from Jul 2, 2026 | |
| 85534-0010-1 | 85534001001 | 60 TABLET in 1 BOTTLE (85534-0010-1)Marketed from Jul 2, 2026 | |
| 85534-0010-2 | 85534001002 | 90 TABLET in 1 BOTTLE (85534-0010-2)Marketed from Jul 2, 2026 | |
| 85534-0010-3 | 85534001003 | 120 TABLET in 1 BOTTLE (85534-0010-3)Marketed from Jul 2, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Gabapentin
- Generic name (nonproprietary)
- gabapentin
- Active ingredients
- Gabapentin — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205101
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 85534-0010_559f2fb7-7b06-ee1a-e063-6394a90a580eSPL ID 559f2fb7-7b06-ee1a-e063-6394a90a580eSPL set ID f6ff265b-569b-4f5c-8fdb-00b7ad4aac7cRxCUI 310433, 310434UNII 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.
- NDC on a medical claim
N485534001000followed by a unit qualifier and the quantityPackage 85534-0010-00. 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)
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 205101
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 600 mg/1 | TabletOral | Proficient Rx LP | 71205-533 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-217 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-517 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Radha Pharmaceuticals, Inc. | 77771-177 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Radha Pharmaceuticals, Inc. | 77771-178 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-145 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-146 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-737 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-767 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-777 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-778 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8490 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8489 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2206 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8491 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8492 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2214 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-743 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-177 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-178 |
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