Prescription drug · ANDA
Gabapentin NDC 71335-2004
Gabapentin 300 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2004-1 | 71335200401 | 90 CAPSULE in 1 BOTTLE (71335-2004-1)Marketed from Feb 10, 2022 | |
| 71335-2004-2 | 71335200402 | 28 CAPSULE in 1 BOTTLE (71335-2004-2)Marketed from Feb 10, 2022 | |
| 71335-2004-3 | 71335200403 | 58 CAPSULE in 1 BOTTLE (71335-2004-3)Marketed from Feb 10, 2022 | |
| 71335-2004-4 | 71335200404 | 30 CAPSULE in 1 BOTTLE (71335-2004-4)Marketed from Feb 10, 2022 | |
| 71335-2004-5 | 71335200405 | 60 CAPSULE in 1 BOTTLE (71335-2004-5)Marketed from Feb 10, 2022 | |
| 71335-2004-6 | 71335200406 | 120 CAPSULE in 1 BOTTLE (71335-2004-6)Marketed from Feb 10, 2022 | |
| 71335-2004-7 | 71335200407 | 180 CAPSULE in 1 BOTTLE (71335-2004-7)Marketed from Feb 10, 2022 | |
| 71335-2004-8 | 71335200408 | 40 CAPSULE in 1 BOTTLE (71335-2004-8)Marketed from Feb 10, 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
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075360
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71335-2004_da9c203e-576a-4c73-b509-b31c44021046SPL ID da9c203e-576a-4c73-b509-b31c44021046SPL set ID 13640281-26b4-402e-8f69-7c81cd6e0376RxCUI 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
N471335200401followed by a unit qualifier and the quantityPackage 71335-2004-01. 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)
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 075360
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 | Bryant Ranch Prepack | 71335-1997 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0150 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-617 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-619 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-661 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc | 70010-928 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc | 70010-926 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc | 70010-927 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-926 |