Prescription drug · ANDA
Gabapentin NDC 71335-2478
Gabapentin 400 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2478-0 | 71335247800 | 180 CAPSULE in 1 BOTTLE (71335-2478-0)Marketed from Sep 3, 2024 | |
| 71335-2478-1 | 71335247801 | 20 CAPSULE in 1 BOTTLE (71335-2478-1)Marketed from Sep 3, 2024 | |
| 71335-2478-2 | 71335247802 | 90 CAPSULE in 1 BOTTLE (71335-2478-2)Marketed from Sep 3, 2024 | |
| 71335-2478-3 | 71335247803 | 60 CAPSULE in 1 BOTTLE (71335-2478-3)Marketed from Sep 3, 2024 | |
| 71335-2478-4 | 71335247804 | 30 CAPSULE in 1 BOTTLE (71335-2478-4)Marketed from Sep 3, 2024 | |
| 71335-2478-5 | 71335247805 | 120 CAPSULE in 1 BOTTLE (71335-2478-5)Marketed from Sep 3, 2024 | |
| 71335-2478-6 | 71335247806 | 21 CAPSULE in 1 BOTTLE (71335-2478-6)Marketed from Sep 3, 2024 | |
| 71335-2478-7 | 71335247807 | 84 CAPSULE in 1 BOTTLE (71335-2478-7)Marketed from Sep 3, 2024 | |
| 71335-2478-8 | 71335247808 | 112 CAPSULE in 1 BOTTLE (71335-2478-8)Marketed from Sep 3, 2024 | |
| 71335-2478-9 | 71335247809 | 28 CAPSULE in 1 BOTTLE (71335-2478-9)Marketed from Sep 3, 2024 |
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 — 400 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 213603
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71335-2478_2973d72c-9629-418f-8443-47ca3a54d352SPL ID 2973d72c-9629-418f-8443-47ca3a54d352SPL set ID 2dad630a-09d8-4f40-bdad-24e877a9ee38RxCUI 310432UNII 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
N471335247800followed by a unit qualifier and the quantityPackage 71335-2478-00. 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 213603
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 100 mg/1 | CapsuleOral | Direct_Rx | 72189-384 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2381 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Zhejiang Yongtai Pharmaceutical Co., Ltd | 69434-042 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Zhejiang Yongtai Pharmaceutical Co., Ltd | 69434-043 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Zhejiang Yongtai Pharmaceutical Co., Ltd | 69434-044 |