Prescription drug · ANDA
Gabapentin NDC 80425-0032
Gabapentin 300 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0032-1 | 80425003201 | 30 CAPSULE in 1 BOTTLE (80425-0032-1)Marketed from Apr 3, 2022 | |
| 80425-0032-2 | 80425003202 | 60 CAPSULE in 1 BOTTLE (80425-0032-2)Marketed from Apr 3, 2022 | |
| 80425-0032-3 | 80425003203 | 90 CAPSULE in 1 BOTTLE (80425-0032-3)Marketed from Apr 3, 2022 |
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 — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075350
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 80425-0032_2a988314-623b-2d61-e063-6294a90a3e84SPL ID 2a988314-623b-2d61-e063-6294a90a3e84SPL set ID afc80b8b-da39-6fb9-e053-2a95a90a2d8eRxCUI 310431UNII 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
N480425003201followed by a unit qualifier and the quantityPackage 80425-0032-01. 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)
1. Indications and Usage Section 1 INDICATIONS AND USAGE Gabapentin capsules are 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075350
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 | Proficient Rx LP | 63187-988 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0351 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-072 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-075 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-081 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 45963-555 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 45963-556 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-064 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 45963-557 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-014 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-015 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-055 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3494 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3495 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3496 |