Pregabalin
- Product NDC
- 70518-3647
- 11-digit product format
- 705183647
- Labeler code
- 70518
- Product ID
- 70518-3647_4f6e6604-5241-ad37-e063-6294a90a537d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207799
- Marketing category
- ANDA
- Marketing start
- 2023-02-16
- Substance
- PREGABALIN
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483440 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3647-0 | Pregabalin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 7 |
| 70518-3647-1 | Pregabalin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3647 | PREGABALIN CAPSULE [REMEDYREPACK INC.] | 4 | Current NDC, 2 package rows | 20241123_efe06a26-30c5-437d-9fd1-4bd0062f1200.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 |
|---|
| 70518-3647-0 | 70518364700 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3647-0) | 90 capsule | 2023-02-16 | No | No | Historical |
| 70518-3647-1 | 70518364701 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3647-1) | 60 capsule | 2023-02-16 | No | No | Historical |