Gabapentin
- Product NDC
- 45865-216
- 11-digit product format
- 458650216
- Labeler code
- 45865
- Product ID
- 45865-216_1277f18a-a854-3b06-e063-6294a90a88b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA206943
- Marketing category
- ANDA
- Marketing start
- 2018-05-14
- Substance
- GABAPENTIN
- Active strength
- 100 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 | 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 |
|---|
| 45865-216-30 | Gabapentin | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 45865-216-51 | Gabapentin | 120 in 1 BOTTLE | CAPSULE | 120 | | 1 |
| 45865-216-60 | Gabapentin | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 45865-216-90 | Gabapentin | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-216 | GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | Current NDC, 4 package rows | 20240301_1278512b-1493-db65-e063-6394a90ab161.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45865-216-30 | 45865021630 | 30 CAPSULE in 1 BOTTLE (45865-216-30) | 30 capsule | 2022-09-15 | No | No | Current |
| 45865-216-51 | 45865021651 | 120 CAPSULE in 1 BOTTLE (45865-216-51) | 120 capsule | 2022-06-02 | No | No | Current |
| 45865-216-60 | 45865021660 | 60 CAPSULE in 1 BOTTLE (45865-216-60) | 60 capsule | 2024-02-23 | No | No | Current |
| 45865-216-90 | 45865021690 | 90 CAPSULE in 1 BOTTLE (45865-216-90) | 90 capsule | 2022-06-13 | No | No | Current |