Gabapentin
- Product NDC
- 51224-121
- 11-digit product format
- 512240121
- Labeler code
- 51224
- Product ID
- 51224-121_001831ce-47e9-4d0e-9aa5-d566575c2267
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- TAGI Pharma, Inc.
- Application
- ANDA207057
- Marketing category
- ANDA
- Marketing start
- 2019-05-01
- Marketing end
- 2026-12-31
- Substance
- GABAPENTIN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 800 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 |
|---|
| 51224-121-50 | Gabapentin | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 6 |
| 51224-121-60 | Gabapentin | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51224-121 | GABAPENTIN TABLET, COATED [TAGI PHARMA, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210903_725878fa-1e2f-4fee-a9e1-a6e102c79625.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 |
|---|
| 51224-121-50 | 51224012150 | 100 TABLET, COATED in 1 BOTTLE (51224-121-50) | 2019-05-01 | 0000-00-00 | No | No | Current |
| 51224-121-60 | 51224012160 | 500 TABLET, COATED in 1 BOTTLE (51224-121-60) | 2019-05-01 | 2026-12-31 | No | No | Current |