Gabapentin
- Product NDC
- 69367-346
- 11-digit product format
- 693670346
- Labeler code
- 69367
- Product ID
- 69367-346_3855844f-e123-4574-8d9b-76397d602744
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA207057
- Marketing category
- ANDA
- Marketing start
- 2021-11-01
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310433, 310434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-346-05 | Gabapentin | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-346 | GABAPENTIN TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241225_2eec52a1-9016-46dd-8b4c-8dab1d0aeece.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69367-346-05 | 69367034605 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-346-05) | 2021-11-01 | 0000-00-00 | No | No | Current |