GABAPENTIN
- Product NDC
- 71610-630
- 11-digit product format
- 716100630
- Labeler code
- 71610
- Product ID
- 71610-630_12e0dcb9-e210-413b-9c77-cdeccd600e82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA214957
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Substance
- GABAPENTIN
- Active strength
- 800 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-630 | GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 8 package rows | 20220512_17988b64-723c-488d-befd-3e4e4cc44bd2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-630-30 | 71610063030 | 30 TABLET in 1 BOTTLE (71610-630-30) | 30 tablet | 2022-04-20 | 0000-00-00 | No | No | Current |
| 71610-630-45 | 71610063045 | 45 TABLET in 1 BOTTLE (71610-630-45) | 45 tablet | 2022-04-20 | 0000-00-00 | No | No | Current |
| 71610-630-53 | 71610063053 | 60 TABLET in 1 BOTTLE (71610-630-53) | 60 tablet | 2022-04-20 | 0000-00-00 | No | No | Current |
| 71610-630-60 | 71610063060 | 90 TABLET in 1 BOTTLE (71610-630-60) | 90 tablet | 2022-04-20 | 0000-00-00 | No | No | Current |
| 71610-630-70 | 71610063070 | 120 TABLET in 1 BOTTLE (71610-630-70) | 120 tablet | 2022-04-20 | 0000-00-00 | No | No | Current |
| 71610-630-73 | 71610063073 | 135 TABLET in 1 BOTTLE (71610-630-73) | 135 tablet | 2022-04-20 | 0000-00-00 | No | No | Current |
| 71610-630-80 | 71610063080 | 180 TABLET in 1 BOTTLE (71610-630-80) | 180 tablet | 2022-01-25 | 0000-00-00 | No | No | Current |
| 71610-630-92 | 71610063092 | 270 TABLET in 1 BOTTLE (71610-630-92) | 270 tablet | 2022-01-25 | 0000-00-00 | No | No | Current |