ARIPIPRAZOLE
- Product NDC
- 16729-281
- 11-digit product format
- 167290281
- Labeler code
- 16729
- Product ID
- 16729-281_40825d37-d601-2272-e063-6294a90af90d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ARIPIPRAZOLE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA206251
- Marketing category
- ANDA
- Marketing start
- 2017-02-15
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-281-01 | ARIPIPRAZOLE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 12 |
| 16729-281-10 | ARIPIPRAZOLE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 12 |
| 16729-281-16 | ARIPIPRAZOLE | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 12 |
| 16729-281-46 | ARIPIPRAZOLE | 100 in 1 BLISTER PACK | TABLET | 100 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-281 | ARIPIPRAZOLE TABLET [ACCORD HEALTHCARE, INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20231122_85cc7d25-414b-4b6f-a03a-48af908a16a1.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 |
|---|
| 16729-281-01 | 16729028101 | 100 TABLET in 1 BOTTLE, PLASTIC (16729-281-01) | 100 tablet | 2017-02-15 | 0000-00-00 | No | No | Current |
| 16729-281-10 | 16729028110 | 30 TABLET in 1 BOTTLE, PLASTIC (16729-281-10) | 30 tablet | 2017-02-15 | 0000-00-00 | No | No | Current |
| 16729-281-16 | 16729028116 | 500 in 1 BOTTLE, PLASTIC | | | | | | Historical |
| 16729-281-46 | 16729028146 | 100 in 1 BLISTER PACK | | | | | | Historical |