Gabapentin
- Product NDC
- 82619-145
- 11-digit product format
- 826190145
- Labeler code
- 82619
- Product ID
- 82619-145_26ce27e6-34a6-70d2-e063-6394a90a7c96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Creekwood Pharmaceuticals LLC
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2024-09-01
- 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 |
|---|
| 82619-145-01 | Gabapentin | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 82619-145-02 | Gabapentin | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82619-145 | GABAPENTIN TABLET [CREEKWOOD PHARMACEUTICALS LLC] | 2 | Current NDC, 2 package rows | 20241115_266ef369-0a56-f225-e063-6294a90a495e.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 |
|---|
| 82619-145-01 | 82619014501 | 100 TABLET in 1 BOTTLE (82619-145-01) | 100 tablet | 2024-09-01 | No | No | Current |
| 82619-145-02 | 82619014502 | 500 TABLET in 1 BOTTLE (82619-145-02) | 500 tablet | 2024-09-01 | No | No | Current |