Prescription drug · ANDA
Gabapentin NDC 71335-1197
Gabapentin 300 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1197-0 | 71335119700 | 20 CAPSULE in 1 BOTTLE (71335-1197-0)Marketed from Aug 24, 2021 | |
| 71335-1197-1 | 71335119701 | 30 CAPSULE in 1 BOTTLE (71335-1197-1)Marketed from Jun 14, 2019 | |
| 71335-1197-2 | 71335119702 | 90 CAPSULE in 1 BOTTLE (71335-1197-2)Marketed from May 7, 2019 | |
| 71335-1197-3 | 71335119703 | 60 CAPSULE in 1 BOTTLE (71335-1197-3)Marketed from Jul 1, 2019 | |
| 71335-1197-4 | 71335119704 | 120 CAPSULE in 1 BOTTLE (71335-1197-4)Marketed from Jul 15, 2019 | |
| 71335-1197-5 | 71335119705 | 100 CAPSULE in 1 BOTTLE (71335-1197-5)Marketed from Jul 15, 2019 | |
| 71335-1197-6 | 71335119706 | 28 CAPSULE in 1 BOTTLE (71335-1197-6)Marketed from Jan 29, 2025 | |
| 71335-1197-7 | 71335119707 | 112 CAPSULE in 1 BOTTLE (71335-1197-7)Marketed from Mar 22, 2024 | |
| 71335-1197-8 | 71335119708 | 84 CAPSULE in 1 BOTTLE (71335-1197-8)Marketed from Jan 29, 2025 | |
| 71335-1197-9 | 71335119709 | 180 CAPSULE in 1 BOTTLE (71335-1197-9)Marketed from Jul 26, 2019 |
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
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090858
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71335-1197_29618b26-10d1-4206-b5e1-be342c7b0563SPL ID 29618b26-10d1-4206-b5e1-be342c7b0563SPL set ID 6a0a75ac-e121-477b-a9d1-d11f588afc9dRxCUI 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
N471335119700followed by a unit qualifier and the quantityPackage 71335-1197-00. 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 090858
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 400 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-059 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-3363 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7614 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-7992 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-7993 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7615 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-234 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3200 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-035 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | American Health Packaging | 60687-580 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | American Health Packaging | 60687-591 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5193 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | American Health Packaging | 60687-602 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0896 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1496 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-143 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7169 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3329 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3330 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | McKesson Corporation dba Sky Packaging | 63739-903 |
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