Prescription drug · ANDA
Gabapentin NDC 45963-557
Gabapentin 400 mg/1 · Capsule · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45963-557-11 | 45963055711 | 100 CAPSULE in 1 BOTTLE (45963-557-11)Marketed from May 12, 2014 | |
| 45963-557-50 | 45963055750 | 500 CAPSULE in 1 BOTTLE (45963-557-50)Marketed from Apr 3, 2014 |
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)
- Gabapentin
- Generic name (nonproprietary)
- gabapentin
- Active ingredients
- Gabapentin — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- 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 45963-557_6928cff7-f264-464c-bd54-baf27f13ab18SPL ID 6928cff7-f264-464c-bd54-baf27f13ab18SPL set ID 5969871e-6c71-4c37-9d63-370718ccc80cRxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0345963555113, 0345963556110
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
N445963055711followed by a unit qualifier and the quantityPackage 45963-0557-11. 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 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 Gabapentin capsules are 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 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 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 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0032 |
| 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 |