Pregabalin
- Product NDC
- 70518-2745
- 11-digit product format
- 705182745
- Labeler code
- 70518
- Product ID
- 70518-2745_4a8d2d82-618d-aa92-e063-6394a90a69f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2020-05-14
- Substance
- PREGABALIN
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-2745-0 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-0 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-0 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-1 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-1 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-1 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
| 70518-2745-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e8b5-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, CV Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2745-0 | Pregabalin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 14 |
| 70518-2745-1 | Pregabalin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 14 |
| 70518-2745-2 | Pregabalin | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2745 | PREGABALIN CAPSULE [REMEDYREPACK INC.] | 9 | Current NDC, Legacy NDC, 3 package rows | 20250402_14f3f9ba-7a4a-45d5-a25e-efe5cdff117d.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 |
|---|
| 70518-2745-0 | 70518274500 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2745-0) | 90 capsule | 2020-05-14 | 0000-00-00 | No | No | Current |
| 70518-2745-1 | 70518274501 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-2745-1) | 60 capsule | 2020-12-28 | 0000-00-00 | No | No | Current |
| 70518-2745-2 | 70518274502 | 30 CAPSULE in 1 BLISTER PACK (70518-2745-2) | 30 capsule | 2023-03-10 | | No | No | Historical |