Gabapentin
- Product NDC
- 45865-194
- 11-digit product format
- 458650194
- Labeler code
- 45865
- Product ID
- 45865-194_12f0b9ce-f0ff-fa26-e063-6394a90aa686
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2016-02-18
- Substance
- GABAPENTIN
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310431 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-194-30 | Gabapentin | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 45865-194-51 | Gabapentin | 120 in 1 BOTTLE | CAPSULE | 120 | | 1 |
| 45865-194-60 | Gabapentin | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 45865-194-90 | 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 |
|---|
| 45865-194 | GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | Current NDC, 4 package rows | 20240307_12f0c2ee-9a44-9778-e063-6294a90a3b58.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 |
|---|
| 45865-194-30 | 45865019430 | 30 CAPSULE in 1 BOTTLE (45865-194-30) | 30 capsule | 2021-08-31 | No | No | Historical |
| 45865-194-51 | 45865019451 | 120 CAPSULE in 1 BOTTLE (45865-194-51) | 120 capsule | 2022-10-18 | No | No | Historical |
| 45865-194-60 | 45865019460 | 60 CAPSULE in 1 BOTTLE (45865-194-60) | 60 capsule | 2021-09-09 | No | No | Historical |
| 45865-194-90 | 45865019490 | 90 CAPSULE in 1 BOTTLE (45865-194-90) | 90 capsule | 2021-08-26 | No | No | Historical |