Prescription drug · ANDA
Gabapentin NDC 83301-0005
Gabapentin 400 mg/1 · Capsule · Oral · Mullan Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83301-0005-1 | 83301000501 | 100 CAPSULE in 1 BOTTLE, PLASTIC (83301-0005-1)Marketed from May 1, 2023 | |
| 83301-0005-2 | 83301000502 | 500 CAPSULE in 1 BOTTLE, PLASTIC (83301-0005-2)Marketed from May 1, 2023 | |
| 83301-0005-3 | 83301000503 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (83301-0005-3)Marketed from May 1, 2023 |
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
- Mullan Pharmaceutical Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075477
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 83301-0005_3ce59317-9cf6-5ae5-e063-6394a90aba6cSPL ID 3ce59317-9cf6-5ae5-e063-6394a90aba6cSPL set ID 74474aa4-4859-42d2-92d8-f23f18b34e04RxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0383301000437, 0383301000338, 0383301000413, 0383301000314, 0383301000512, 0383301000529, 0383301000321, 0383301000420
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
N483301000501followed by a unit qualifier and the quantityPackage 83301-0005-01. 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 075477
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 | Westminster Pharmaceuticals, LLC | 69367-344 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0196 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-343 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-345 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0199 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0286 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Proficient Rx LP | 82804-217 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Mullan Pharmaceutical Inc. | 83301-0004 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Mullan Pharmaceutical Inc. | 83301-0003 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-226 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3527 |