PREGABALIN
- Product NDC
- 39328-090
- 11-digit product format
- 393280090
- Labeler code
- 39328
- Product ID
- 39328-090_3a08157d-abaf-445c-b333-c209ef961bc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Patrin Pharma, Inc.
- Application
- ANDA212604
- Marketing category
- ANDA
- Marketing start
- 2022-06-14
- Substance
- PREGABALIN
- Active strength
- 20 mg/mL
- 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 898715 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39328-090-16 | PREGABALIN | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 39328-090-16 | PREGABALIN | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39328-090 | PREGABALIN SOLUTION [PATRIN PHARMA, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220626_d92c94e5-e542-4177-afa8-fa00ba17634c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 39328-090-16 | 39328009016 | 1 BOTTLE, PLASTIC in 1 CARTON (39328-090-16) / 473 mL in 1 BOTTLE, PLASTIC | 2022-06-14 | 0000-00-00 | No | No | Current |