Pregabalin
- Product NDC
- 68788-7521
- 11-digit product format
- 687887521
- Labeler code
- 68788
- Product ID
- 68788-7521_7f697241-584d-4ef6-8018-35d302908108
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- 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 | 483448 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7521-1 | Pregabalin | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
| 68788-7521-3 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
| 68788-7521-6 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
| 68788-7521-9 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7521 | PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240802_3dbfd868-8408-4514-ba1c-04a5d095c16a.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 |
|---|
| 68788-7521-1 | 68788752101 | 100 CAPSULE in 1 BOTTLE (68788-7521-1) | 100 capsule | 2019-10-28 | 0000-00-00 | No | No | Current |
| 68788-7521-3 | 68788752103 | 30 CAPSULE in 1 BOTTLE (68788-7521-3) | 30 capsule | 2019-10-28 | 0000-00-00 | No | No | Current |
| 68788-7521-6 | 68788752106 | 60 CAPSULE in 1 BOTTLE (68788-7521-6) | 60 capsule | 2019-10-28 | 0000-00-00 | No | No | Current |
| 68788-7521-9 | 68788752109 | 90 CAPSULE in 1 BOTTLE (68788-7521-9) | 90 capsule | 2019-10-28 | 0000-00-00 | No | No | Current |