PREGABALIN
- Product NDC
- 71335-1505
- 11-digit product format
- 713351505
- Labeler code
- 71335
- Product ID
- 71335-1505_ef869518-e222-4dab-a77b-820fec1ce911
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210432
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483444 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1505-1 | 2024-05-20 | C162847 | 48780-1 | 1030e365-403d-111a-e063-dadaa90a10e2 | 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, for oral use, CV Initial U.S. Approval: 2004 |
| 71335-1505-2 | 2024-05-20 | C162847 | 48780-1 | 1030e365-403d-111a-e063-dadaa90a10e2 | 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, for oral use, CV Initial U.S. Approval: 2004 |
| 71335-1505-3 | 2024-05-20 | C162847 | 48780-1 | 1030e365-403d-111a-e063-dadaa90a10e2 | 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, for oral use, CV Initial U.S. Approval: 2004 |
| 71335-1505-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-403d-111a-e063-dadaa90a10e2 | 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, for oral use, CV Initial U.S. Approval: 2004 |
| 71335-1505-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-403d-111a-e063-dadaa90a10e2 | 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, for oral use, CV Initial U.S. Approval: 2004 |
| 71335-1505-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-403d-111a-e063-dadaa90a10e2 | 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, for oral use, CV Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1505-1 | PREGABALIN | 60 in 1 BOTTLE | CAPSULE | 60 | | 103 |
| 71335-1505-2 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 103 |
| 71335-1505-3 | PREGABALIN | 30 in 1 BOTTLE | CAPSULE | 30 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1505 | PREGABALIN CAPSULE [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 3 package rows | 20240522_15b5e3d0-2bad-4363-99cb-e15819c41fda.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 |
|---|
| 71335-1505-1 | 71335150501 | 60 CAPSULE in 1 BOTTLE (71335-1505-1) | 60 capsule | 2020-02-19 | 0000-00-00 | No | No | Current |
| 71335-1505-2 | 71335150502 | 90 CAPSULE in 1 BOTTLE (71335-1505-2) | 90 capsule | 2022-09-20 | 0000-00-00 | No | No | Current |
| 71335-1505-3 | 71335150503 | 30 CAPSULE in 1 BOTTLE (71335-1505-3) | 30 capsule | 2022-09-20 | 0000-00-00 | No | No | Current |