Pregabalin
- Product NDC
- 82804-170
- 11-digit product format
- 828040170
- Labeler code
- 82804
- Product ID
- 82804-170_e80b626b-701e-4b20-a6b3-77b064c8d495
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA206912
- Marketing category
- ANDA
- Marketing start
- 2019-10-08
- 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 | 483450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-170-60 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
| 82804-170-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-170 | PREGABALIN CAPSULE [PROFICIENT RX LP] | 2 | Current NDC, 2 package rows | 20250331_a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e.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 |
|---|
| 82804-170-60 | 82804017060 | 60 CAPSULE in 1 BOTTLE (82804-170-60) | 60 capsule | 2024-12-03 | No | No | Current |
| 82804-170-90 | 82804017090 | 90 CAPSULE in 1 BOTTLE (82804-170-90) | 90 capsule | 2025-03-26 | No | No | Current |