Gabapentin
- Product NDC
- 71610-421
- 11-digit product format
- 716100421
- Labeler code
- 71610
- Product ID
- 71610-421_21d2a6c0-a9bc-4a72-aca2-86a7e840c914
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2016-02-18
- Substance
- GABAPENTIN
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310430 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-421-30 | Gabapentin | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 7 |
| 71610-421-53 | Gabapentin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 7 |
| 71610-421-60 | Gabapentin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 7 |
| 71610-421-80 | Gabapentin | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-421 | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20221129_20e48004-d8b6-40fd-929b-b95087b4d85d.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 |
|---|
| 71610-421-30 | 71610042130 | 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-30) | 30 capsule | 2020-07-29 | 0000-00-00 | No | No | Current |
| 71610-421-53 | 71610042153 | 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-53) | 60 capsule | 2020-05-01 | 0000-00-00 | No | No | Current |
| 71610-421-60 | 71610042160 | 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-60) | 90 capsule | 2022-10-17 | 0000-00-00 | No | No | Current |
| 71610-421-80 | 71610042180 | 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-80) | 180 capsule | 2022-11-23 | 0000-00-00 | No | No | Current |