pregabalin
- Product NDC
- 43598-295
- 11-digit product format
- 435980295
- Labeler code
- 43598
- Product ID
- 43598-295_4a1e5038-d049-606f-c087-48bc353a8a69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA209664
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 150 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 | 150 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-295 | PREGABALIN CAPSULE [DR.REDDYS LABORATORIES INC] | 12 | Current NDC, Legacy NDC, 5 package rows | 20240228_ceed457b-8f43-4021-fd70-071c96e09470.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 |
|---|
| 43598-295-05 | 43598029505 | 500 CAPSULE in 1 BOTTLE (43598-295-05) | 500 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 43598-295-66 | 43598029566 | 5 BLISTER PACK in 1 CARTON (43598-295-66) / 10 CAPSULE in 1 BLISTER PACK (43598-295-79) | 5 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |
| 43598-295-78 | 43598029578 | 10 BLISTER PACK in 1 CARTON (43598-295-78) / 10 CAPSULE in 1 BLISTER PACK (43598-295-79) | 10 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |
| 43598-295-79 | 43598029579 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 43598-295-90 | 43598029590 | 90 CAPSULE in 1 BOTTLE (43598-295-90) | 90 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |