Pregabalin
- Product NDC
- 70518-3597
- 11-digit product format
- 705183597
- Labeler code
- 70518
- Product ID
- 70518-3597_4f5c61f4-9af9-8662-e063-6394a90a8a22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207799
- Marketing category
- ANDA
- Marketing start
- 2022-12-21
- Substance
- PREGABALIN
- Active strength
- 75 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
- Listing expiration
- 2027-12-31
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 |
|---|
| 70518-3597-0 | Pregabalin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 8 |
| 70518-3597-1 | Pregabalin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 8 |
| 70518-3597-2 | Pregabalin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 8 |
| 70518-3597-3 | Pregabalin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3597 | PREGABALIN CAPSULE [REMEDYREPACK INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241218_12309847-0857-4ff7-a7e7-edeadc3dfb61.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 |
|---|
| 70518-3597-0 | 70518359700 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3597-0) | 90 capsule | 2022-12-21 | 0000-00-00 | No | No | Current |
| 70518-3597-1 | 70518359701 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3597-1) | 60 capsule | 2023-02-16 | | No | No | Current |
| 70518-3597-2 | 70518359702 | 90 in 1 BOTTLE, PLASTIC | | | | | | Historical |
| 70518-3597-3 | 70518359703 | 60 in 1 BOTTLE, PLASTIC | | | | | | Historical |