Aripiprazole
- Product NDC
- 46708-261
- 11-digit product format
- 467080261
- Labeler code
- 46708
- Product ID
- 46708-261_1ea06df8-17dc-46eb-921a-2b52d41ea622
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202102
- Marketing category
- ANDA
- Marketing start
- 2015-05-21
- 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 | 643019, 643022 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-261-10 | Aripiprazole | 30 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-261 | ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230202_4f1691a8-724e-430d-9bab-27b59ef9bd4e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-261-10 | 46708026110 | 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (46708-261-10) | 2015-05-21 | 0000-00-00 | No | No | Current |