Gabapentin
- Product NDC
- 0121-2134
- 11-digit product format
- 001212134
- Labeler code
- 0121
- Product ID
- 0121-2134_01ef9bd4-78c9-4ec7-8633-c4e0260ad2de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA211330
- Marketing category
- ANDA
- Marketing start
- 2025-06-12
- Substance
- GABAPENTIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 283523 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-2134-06 | Gabapentin | 6 mL in 1 CUP, UNIT-DOSE | SOLUTION | 6 | | 3 |
| 0121-2134-40 | Gabapentin | 10 in 1 TRAY | SOLUTION | 10 | | 3 |
| 0121-2134-40 | Gabapentin | 4 in 1 CASE | SOLUTION | 4 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-2134-06 | 00121213406 | 6 mL in 1 CUP, UNIT-DOSE | 6 ml | | | | Historical |
| 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) | 4 tray | 2025-06-12 | No | No | Historical |