Gabapentin
- Product NDC
- 43353-081
- 11-digit product format
- 433530081
- Labeler code
- 43353
- Product ID
- 43353-081_c53f4d79-df8d-42b8-86e3-bd6181049abc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075350
- Marketing category
- ANDA
- Marketing start
- 2014-03-17
- Substance
- GABAPENTIN
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310431, 310432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-081-60 | Gabapentin | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
| 43353-081-80 | Gabapentin | 180 in 1 BOTTLE | CAPSULE | 180 | | 1 |
| 43353-081-92 | Gabapentin | 270 in 1 BOTTLE | CAPSULE | 270 | | 1 |
| 43353-081-94 | Gabapentin | 360 in 1 BOTTLE | CAPSULE | 360 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-081 | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 4 package rows | 20160707_86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49.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 |
|---|
| 43353-081-60 | 43353008160 | 90 CAPSULE in 1 BOTTLE (43353-081-60) | 90 capsule | 2015-07-11 | 0000-00-00 | No | No | Current |
| 43353-081-80 | 43353008180 | 180 CAPSULE in 1 BOTTLE (43353-081-80) | 180 capsule | 2015-11-07 | 0000-00-00 | No | No | Current |
| 43353-081-92 | 43353008192 | 270 CAPSULE in 1 BOTTLE (43353-081-92) | 270 capsule | 2016-01-28 | 0000-00-00 | No | No | Current |
| 43353-081-94 | 43353008194 | 360 CAPSULE in 1 BOTTLE (43353-081-94) | 360 capsule | 2015-11-08 | 0000-00-00 | No | No | Current |