Aripiprazole
- Product NDC
- 46708-256
- 11-digit product format
- 467080256
- Labeler code
- 46708
- Product ID
- 46708-256_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
- 10 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 | 10 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 |
|---|
| 46708-256-10 | 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 |
| 46708-256-30 | 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 |
| 46708-256-31 | 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 |
| 46708-256-71 | 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 |
| 46708-256-91 | 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 |
| 46708-256-10 | 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 |
| 46708-256-30 | 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 |
| 46708-256-31 | 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 |
| 46708-256-71 | 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 |
| 46708-256-91 | 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 |
|---|
| 46708-256-10 | Aripiprazole | 100 in 1 CARTON | TABLET | 100 | | 3 |
| 46708-256-30 | Aripiprazole | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 46708-256-31 | Aripiprazole | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 46708-256-71 | Aripiprazole | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 46708-256-91 | 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 |
|---|
| 46708-256 | 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 |
|---|
| 46708-256-10 | 46708025610 | 100 TABLET in 1 CARTON (46708-256-10) | 100 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-256-30 | 46708025630 | 30 TABLET in 1 BOTTLE (46708-256-30) | 30 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-256-31 | 46708025631 | 100 TABLET in 1 BOTTLE (46708-256-31) | 100 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-256-71 | 46708025671 | 500 TABLET in 1 BOTTLE (46708-256-71) | 500 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 46708-256-91 | 46708025691 | 1000 TABLET in 1 BOTTLE (46708-256-91) | 1000 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |