Gabapentin
- Product NDC
- 16571-226
- 11-digit product format
- 165710226
- Labeler code
- 16571
- Product ID
- 16571-226_e4b713f1-a833-4fc7-8a0f-696077ddc280
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA217995
- Marketing category
- ANDA
- Marketing start
- 2024-04-04
- Substance
- GABAPENTIN
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310433 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-226-01 | Gabapentin | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 16571-226-50 | Gabapentin | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-226 | GABAPENTIN TABLET [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 2 package rows | 20240405_8215da86-d7af-4980-b6d6-4bd46f6bfeaf.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 |
|---|
| 16571-226-01 | 16571022601 | 100 TABLET in 1 BOTTLE (16571-226-01) | 100 tablet | 2024-04-04 | No | No | Historical |
| 16571-226-50 | 16571022650 | 500 TABLET in 1 BOTTLE (16571-226-50) | 500 tablet | 2024-04-04 | No | No | Historical |