Prescription drug · ANDA
Gabapentin NDC 81033-123
Gabapentin 250 mg/5mL · Solution · Oral · Kesin Pharma Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81033-123-16 | 81033012316 | 473 mL in 1 BOTTLE (81033-123-16)Marketed from Sep 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 250 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Kesin Pharma Corporation
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091286
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 81033-123_4470a571-3213-9849-e063-6394a90a39b2SPL ID 4470a571-3213-9849-e063-6394a90a39b2SPL set ID 4470a567-93a6-a293-e063-6394a90affc1RxCUI 283523UNII 6CW7F3G59XUPC 0381033123165
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
N481033012316followed by a unit qualifier and the quantityPackage 81033-0123-16. 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 oral solution 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 oral solution 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 091286
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 250 mg/5mL | SolutionOral | JVET PHARMACEUTICALS LLC | 86211-112 |
| Gabapentin | Gabapentin 250 mg/5mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-423 |
| Gabapentin | Gabapentin 50 mg/mL | SolutionOral | Kesin Pharma Corporation | 81033-124 |