Aripiprazole
- Product NDC
- 46708-257
- 11-digit product format
- 467080257
- Labeler code
- 46708
- Product ID
- 46708-257_5108607e-5633-4b19-82f9-6c48720960c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202101
- Marketing category
- ANDA
- Marketing start
- 2015-04-28
- Substance
- ARIPIPRAZOLE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aripiprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARIPIPRAZOLE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82VFR53I78 |
| Rxcui | 349490, 349545, 349547, 349553, 402131, 602964 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-257-10 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-30 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-31 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-71 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-91 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-10 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-31 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-71 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
| 46708-257-91 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3460-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-257-10 | Aripiprazole | 100 in 1 CARTON | TABLET | 100 | | 3 |
| 46708-257-30 | Aripiprazole | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 46708-257-31 | Aripiprazole | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 46708-257-71 | Aripiprazole | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 46708-257-91 | Aripiprazole | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-257 | ARIPIPRAZOLE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 5 package rows | 20230202_793fc904-2f11-4f97-a0ac-4d6910cac0f9.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 |
|---|
| 46708-257-10 | 46708025710 | 100 TABLET in 1 CARTON (46708-257-10) | 100 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-257-30 | 46708025730 | 30 TABLET in 1 BOTTLE (46708-257-30) | 30 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-257-31 | 46708025731 | 100 TABLET in 1 BOTTLE (46708-257-31) | 100 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-257-71 | 46708025771 | 500 TABLET in 1 BOTTLE (46708-257-71) | 500 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-257-91 | 46708025791 | 1000 TABLET in 1 BOTTLE (46708-257-91) | 1000 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |