GABAPENTIN
- Product NDC
- 31722-069
- 11-digit product format
- 317220069
- Labeler code
- 31722
- Product ID
- 31722-069_45c076af-c121-6962-e063-6394a90aaad1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA217682
- Marketing category
- ANDA
- Marketing start
- 2024-01-17
- 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 |
|---|
| 31722-069-47 | GABAPENTIN | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 31722-069-47 | GABAPENTIN | 470 mL in 1 BOTTLE | SOLUTION | 470 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-069 | GABAPENTIN (GABAPENTIN) SOLUTION [CAMBER PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20241023_b86c81d9-9a4a-4847-be18-520e5cc5dc4b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-069-47 | 31722006947 | 1 BOTTLE in 1 CARTON (31722-069-47) / 470 mL in 1 BOTTLE | 1 bottle | 2024-01-17 | No | No | Current |