Gabapentin
- Product NDC
- 76420-015
- 11-digit product format
- 764200015
- Labeler code
- 76420
- Product ID
- 76420-015_ead11d10-7482-8d9b-e053-2a95a90a2c68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA075350
- Marketing category
- ANDA
- Marketing start
- 2014-04-03
- Substance
- GABAPENTIN
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310430, 310431 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-015-24 | Gabapentin | 240 in 1 BOTTLE | CAPSULE | 240 | | 2 |
| 76420-015-30 | Gabapentin | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 76420-015-60 | Gabapentin | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
| 76420-015-90 | Gabapentin | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-015 | GABAPENTIN CAPSULE [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20221013_e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc8.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 |
|---|
| 76420-015-24 | 76420001524 | 240 CAPSULE in 1 BOTTLE (76420-015-24) | 240 capsule | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-015-30 | 76420001530 | 30 CAPSULE in 1 BOTTLE (76420-015-30) | 30 capsule | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-015-60 | 76420001560 | 60 CAPSULE in 1 BOTTLE (76420-015-60) | 60 capsule | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-015-90 | 76420001590 | 90 CAPSULE in 1 BOTTLE (76420-015-90) | 90 capsule | 2020-01-23 | 0000-00-00 | No | No | Current |