Pregabalin
- Product NDC
- 47335-688
- 11-digit product format
- 473350688
- Labeler code
- 47335
- Product ID
- 47335-688_52bb3d43-24c1-4789-8423-6c2d54850e75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA091157
- Marketing category
- ANDA
- Marketing start
- 2019-12-04
- Substance
- PREGABALIN
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-688-08 | Pregabalin | 100 in 1 BOTTLE | CAPSULE | 100 | | 11 |
| 47335-688-18 | Pregabalin | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 11 |
| 47335-688-83 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 11 |
| 47335-688-88 | Pregabalin | 100 in 1 BOTTLE | CAPSULE | 100 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-688 | PREGABALIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20240118_ee7b9119-e88f-48ad-ae97-55e53374e62f.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 |
|---|
| 47335-688-08 | 47335068808 | 100 CAPSULE in 1 BOTTLE (47335-688-08) | 100 capsule | 2019-12-04 | 0000-00-00 | No | No | Current |
| 47335-688-18 | 47335068818 | 1000 CAPSULE in 1 BOTTLE (47335-688-18) | 1000 capsule | 2019-12-04 | 0000-00-00 | No | No | Current |
| 47335-688-83 | 47335068883 | 30 CAPSULE in 1 BOTTLE (47335-688-83) | 30 capsule | 2019-12-04 | 0000-00-00 | No | No | Current |
| 47335-688-88 | 47335068888 | 100 CAPSULE in 1 BOTTLE (47335-688-88) | 100 capsule | 2019-12-04 | 0000-00-00 | No | No | Current |