Gabapentin
- Product NDC
- 82009-072
- 11-digit product format
- 820090072
- Labeler code
- 82009
- Product ID
- 82009-072_f3eaa220-daf6-41ed-a5a2-4656c4a389d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- QUALLENT PHARMACEUTICALS HEALTH LLC
- Application
- ANDA200651
- Marketing category
- ANDA
- Marketing start
- 2023-09-01
- Substance
- GABAPENTIN
- Active strength
- 800 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 | 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 |
|---|
| 82009-072-05 | Gabapentin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-072 | GABAPENTIN TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 4 | Current NDC, 1 package rows | 20241115_472bb279-bb4e-4246-b2a3-172483ba356b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-072-05 | 82009007205 | 500 TABLET, FILM COATED in 1 BOTTLE (82009-072-05) | 2023-09-01 | No | No | Current |