GABAPENTIN
- Product NDC
- 49483-605
- 11-digit product format
- 494830605
- Labeler code
- 49483
- Product ID
- 49483-605_39a5daea-e195-c00b-e063-6394a90a42a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC
- Application
- ANDA090007
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- 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, 310431, 310432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-605-01 | GABAPENTIN | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 49483-605-10 | GABAPENTIN | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 10 |
| 49483-605-50 | GABAPENTIN | 500 in 1 BOTTLE | CAPSULE | 500 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-605 | GABAPENTIN CAPSULE GABAPENTIN CAPSULE [TIME CAP LABORATORIES, INC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20241013_08880902-bd44-41b6-866b-2cbad4c3f2b1.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 |
|---|
| 49483-605-01 | 49483060501 | 100 CAPSULE in 1 BOTTLE (49483-605-01) | 100 capsule | 2015-12-30 | 0000-00-00 | No | No | Current |
| 49483-605-10 | 49483060510 | 1000 CAPSULE in 1 BOTTLE (49483-605-10) | 1000 capsule | 2021-04-17 | 0000-00-00 | No | No | Current |
| 49483-605-50 | 49483060550 | 500 CAPSULE in 1 BOTTLE (49483-605-50) | 500 capsule | 2015-12-30 | 0000-00-00 | No | No | Current |