GABAPENTIN
- Product NDC
- 76282-405
- 11-digit product format
- 762820405
- Labeler code
- 76282
- Product ID
- 76282-405_20a38b18-352b-47a6-b640-091b42db10aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals Inc.
- Application
- ANDA202764
- Marketing category
- ANDA
- Marketing start
- 2012-11-02
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 76282-405-01 | 2023-03-23 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
| 76282-405-05 | 2023-03-23 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
| 76282-405-30 | 2023-03-23 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
| 76282-405-90 | 2023-03-23 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
| 76282-405-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
| 76282-405-05 | 2023-01-30 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
| 76282-405-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
| 76282-405-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-dfee-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-405-01 | GABAPENTIN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 76282-405-05 | GABAPENTIN | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 76282-405-30 | GABAPENTIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 76282-405-90 | GABAPENTIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-405 | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20230324_323dad14-ded9-4432-a265-c957e46cc6db.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 |
|---|
| 76282-405-01 | 76282040501 | 100 TABLET, FILM COATED in 1 BOTTLE (76282-405-01) | 2012-11-02 | 0000-00-00 | No | No | Current |
| 76282-405-05 | 76282040505 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-405-05) | 2012-11-02 | 0000-00-00 | No | No | Current |
| 76282-405-30 | 76282040530 | 30 TABLET, FILM COATED in 1 BOTTLE (76282-405-30) | 2012-11-02 | 0000-00-00 | No | No | Current |
| 76282-405-90 | 76282040590 | 90 TABLET, FILM COATED in 1 BOTTLE (76282-405-90) | 2012-11-02 | 0000-00-00 | No | No | Current |