Gabapentin
- Product NDC
- 71093-122
- 11-digit product format
- 710930122
- Labeler code
- 71093
- Product ID
- 71093-122_a916797c-381c-4008-b778-19221233ef45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ACI Healthcare USA, Inc.
- Application
- ANDA206943
- Marketing category
- ANDA
- Marketing start
- 2018-05-14
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- 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 | 310430, 310431, 310432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71093-122-04 | Gabapentin | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 9 |
| 71093-122-05 | Gabapentin | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71093-122 | GABAPENTIN CAPSULE [ACI HEALTHCARE USA, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20231218_7538e255-95df-4991-aae0-a90d709f1e95.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 |
|---|
| 71093-122-04 | 71093012204 | 100 CAPSULE in 1 BOTTLE, PLASTIC (71093-122-04) | 100 capsule | 2018-08-04 | 0000-00-00 | No | No | Current |
| 71093-122-05 | 71093012205 | 500 CAPSULE in 1 BOTTLE, PLASTIC (71093-122-05) | 500 capsule | 2018-08-04 | 0000-00-00 | No | No | Current |