Gabapentin
- Product NDC
- 80425-0201
- 11-digit product format
- 804250201
- Labeler code
- 80425
- Product ID
- 80425-0201_2a99e9e8-3d19-ee0b-e063-6294a90ae4ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA207057
- Marketing category
- ANDA
- Marketing start
- 2022-10-28
- 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 |
|---|
| 80425-0201-1 | Gabapentin | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 9 |
| 80425-0201-2 | Gabapentin | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 9 |
| 80425-0201-3 | Gabapentin | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 9 |
| 80425-0201-4 | Gabapentin | 120 in 1 BOTTLE | TABLET, COATED | 120 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0201 | GABAPENTIN TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250101_ec1a01fe-5531-21df-e053-2a95a90a0561.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0201-1 | 80425020101 | 30 TABLET, COATED in 1 BOTTLE (80425-0201-1) | 2022-10-28 | No | No | Current |
| 80425-0201-2 | 80425020102 | 60 TABLET, COATED in 1 BOTTLE (80425-0201-2) | 2022-10-28 | No | No | Current |
| 80425-0201-3 | 80425020103 | 90 TABLET, COATED in 1 BOTTLE (80425-0201-3) | 2022-10-28 | No | No | Current |
| 80425-0201-4 | 80425020104 | 120 TABLET, COATED in 1 BOTTLE (80425-0201-4) | 2022-10-28 | No | No | Current |