Gabapentin
- Product NDC
- 77771-178
- 11-digit product format
- 777710178
- Labeler code
- 77771
- Product ID
- 77771-178_39ed0291-41ed-48d4-b11b-6deae3269f32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Radha Pharmaceuticals, Inc.
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2023-11-03
- Substance
- GABAPENTIN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2027-12-31
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 |
|---|
| 77771-178-05 | Gabapentin | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 77771-178-90 | Gabapentin | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 77771-178 | GABAPENTIN TABLET [RADHA PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20231110_1045db4e-4c76-4a0d-bf12-019bd96a8f59.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 |
|---|
| 77771-178-05 | 77771017805 | 500 TABLET in 1 BOTTLE (77771-178-05) | 500 tablet | 2023-11-03 | No | No | Current |
| 77771-178-90 | 77771017890 | 90 TABLET in 1 BOTTLE (77771-178-90) | 90 tablet | 2023-11-03 | No | No | Current |