Aripiprazole
- Product NDC
- 82009-089
- 11-digit product format
- 820090089
- Labeler code
- 82009
- Product ID
- 82009-089_5c525d81-2a40-4c63-a28c-94865bf0c493
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA206174
- Marketing category
- ANDA
- Marketing start
- 2023-07-19
- Substance
- ARIPIPRAZOLE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82VFR53I78 |
| Rxcui | 349490, 349545, 402131, 602964 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-089-05 | Aripiprazole | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-089 | ARIPIPRAZOLE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] | 3 | Current NDC, 1 package rows | 20250418_0e0d42ad-f4c6-4e30-adc2-ab1d122428ec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-089-05 | 82009008905 | 500 TABLET in 1 BOTTLE (82009-089-05) | 500 tablet | 2023-07-19 | No | No | Current |