Prescription drug · ANDA
Gabapentin NDC 0121-2134
Gabapentin 250 mg/5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-2134-40 | 00121213440 | 4 TRAY in 1 CASE (0121-2134-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 6 mL in 1 CUP, UNIT-DOSE (0121-2134-06)Marketed from Jun 12, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211330
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0121-2134_01ef9bd4-78c9-4ec7-8633-c4e0260ad2deSPL ID 01ef9bd4-78c9-4ec7-8633-c4e0260ad2deSPL set ID 6d3fd1f9-c831-4262-af10-291838a53541RxCUI 283523UNII 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
N400121213440followed by a unit qualifier and the quantityPackage 00121-2134-40. 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 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 211330
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 | PAI Holdings, LLC dba PAI Pharma | 0121-1067 |
| Gabapentin | Gabapentin 250 mg/5mL | SolutionOral | American Health Packaging | 60687-919 |
| Gabapentin | Gabapentin 250 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4067 |