Prescription drug · ANDA
Gabapentin NDC 71335-1991
Gabapentin 100 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1991-0 | 71335199100 | 65 CAPSULE in 1 BOTTLE (71335-1991-0)Marketed from Oct 31, 2024 | |
| 71335-1991-1 | 71335199101 | 56 CAPSULE in 1 BOTTLE (71335-1991-1)Marketed from Oct 31, 2024 | |
| 71335-1991-2 | 71335199102 | 90 CAPSULE in 1 BOTTLE (71335-1991-2)Marketed from Jan 14, 2022 | |
| 71335-1991-3 | 71335199103 | 30 CAPSULE in 1 BOTTLE (71335-1991-3)Marketed from Jan 13, 2022 | |
| 71335-1991-4 | 71335199104 | 60 CAPSULE in 1 BOTTLE (71335-1991-4)Marketed from Jan 27, 2022 | |
| 71335-1991-5 | 71335199105 | 28 CAPSULE in 1 BOTTLE (71335-1991-5)Marketed from Oct 31, 2024 | |
| 71335-1991-6 | 71335199106 | 360 CAPSULE in 1 BOTTLE (71335-1991-6)Marketed from Oct 31, 2024 | |
| 71335-1991-7 | 71335199107 | 120 CAPSULE in 1 BOTTLE (71335-1991-7)Marketed from Feb 11, 2022 | |
| 71335-1991-8 | 71335199108 | 100 CAPSULE in 1 BOTTLE (71335-1991-8)Marketed from Oct 31, 2024 | |
| 71335-1991-9 | 71335199109 | 84 CAPSULE in 1 BOTTLE (71335-1991-9)Marketed from Oct 31, 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 — 100 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 090007
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71335-1991_4c1b2f3e-69c7-4575-801f-a3b5a10b1478SPL ID 4c1b2f3e-69c7-4575-801f-a3b5a10b1478SPL set ID e2d9bd8c-3bb9-4945-8e61-7d2703d9008cRxCUI 310430UNII 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
N471335199100followed by a unit qualifier and the quantityPackage 71335-1991-00. 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 Capsules, USP 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 090007
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 | Bi-Coastal Pharma International LLC | 42582-115 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bi-Coastal Pharma International LLC | 42582-114 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bi-Coastal Pharma International LLC | 42582-116 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7024 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | DIRECT RX | 72189-109 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | DIRECT RX | 72189-113 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0993 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-088 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1490 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-103 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-104 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-105 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4784 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-123 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | DIRECT RX | 61919-640 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0079 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2005 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-605 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-606 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-607 |
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