Prescription drug · ANDA
Gabapentin NDC 80425-0079
Gabapentin 300 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0079-1 | 80425007901 | 30 CAPSULE in 1 BOTTLE (80425-0079-1)Marketed from Dec 30, 2015 | |
| 80425-0079-2 | 80425007902 | 60 CAPSULE in 1 BOTTLE (80425-0079-2)Marketed from Dec 30, 2015 | |
| 80425-0079-3 | 80425007903 | 90 CAPSULE in 1 BOTTLE (80425-0079-3)Marketed from Dec 30, 2015 |
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
- 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 80425-0079_2a9914d0-6556-747c-e063-6294a90a946cSPL ID 2a9914d0-6556-747c-e063-6294a90a946cSPL set ID b062f12c-a745-76d4-e053-2a95a90a3a1aRxCUI 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
N480425007901followed by a unit qualifier and the quantityPackage 80425-0079-01. 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)
1. Indications and Usage 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
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 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1991 |
| 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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