Pregabalin
- Product NDC
- 60687-484
- 11-digit product format
- 606870484
- Labeler code
- 60687
- Product ID
- 60687-484_1ac6cf05-42a1-4456-e063-6394a90a5c9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA210432
- Marketing category
- ANDA
- Marketing start
- 2019-08-12
- Substance
- PREGABALIN
- Active strength
- 50 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438, 483440, 483442, 483448, 483450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-484-01 | Pregabalin | 100 in 1 BOX, UNIT-DOSE | CAPSULE | 100 | | 4 |
| 60687-484-11 | Pregabalin | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-484 | PREGABALIN CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240710_59da1a16-d409-49eb-9b44-397c77006043.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 |
|---|
| 60687-484-01 | 60687048401 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-484-01) / 1 CAPSULE in 1 BLISTER PACK (60687-484-11) | 100 blister pack | 2019-08-12 | 0000-00-00 | No | No | Current |
| 60687-484-11 | 60687048411 | 1 in 1 BLISTER PACK | | | | | | Historical |