Gabapentin
- Product NDC
- 42582-116
- 11-digit product format
- 425820116
- Labeler code
- 42582
- Product ID
- 42582-116_2623362f-c5cd-4880-bb49-2d64bedf7be0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bi-Coastal Pharma International LLC
- Application
- ANDA090007
- Marketing category
- ANDA
- Marketing start
- 2016-04-13
- 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 | 310430, 310431, 310432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42582-116-10 | Gabapentin | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 2 |
| 42582-116-18 | Gabapentin | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42582-116 | GABAPENTIN CAPSULE [BI-COASTAL PHARMA INTERNATIONAL LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20160418_e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b.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 |
|---|
| 42582-116-10 | 42582011610 | 100 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-10) | 100 capsule | 2016-04-13 | 0000-00-00 | No | No | Current |
| 42582-116-18 | 42582011618 | 500 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-18) | 500 capsule | 2016-04-13 | 0000-00-00 | No | No | Current |