Aripiprazole
- Product NDC
- 65162-893
- 11-digit product format
- 651620893
- Labeler code
- 65162
- Product ID
- 65162-893_d6606ae3-90c2-4332-ab9f-da0b1c593c88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203906
- Marketing category
- ANDA
- Marketing start
- 2015-08-17
- Substance
- ARIPIPRAZOLE
- Active strength
- 1 mg/mL
- 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82VFR53I78 |
| Rxcui | 485496 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-893-74 | Aripiprazole | 1 in 1 CARTON | SOLUTION | 1 | | 34 |
| 65162-893-74 | Aripiprazole | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 34 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ARIPIPRAZOLE | ACTIVE INGREDIENT | 82VFR53I78 | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| ARIPIPRAZOLE | ACTIVE MOIETY | 82VFR53I78 | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| FRUCTOSE | INACTIVE INGREDIENT | 6YSS42VSEV | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| MALIC ACID | INACTIVE INGREDIENT | 817L1N4CKP | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-893 | ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 34 | Current NDC, Legacy NDC, 2 package rows | 20250227_7f272100-e02f-4a16-bb39-a2bf844db4f9.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 |
|---|
| 65162-893-74 | 65162089374 | 1 BOTTLE in 1 CARTON (65162-893-74) / 150 mL in 1 BOTTLE | 1 bottle | 2015-08-17 | 0000-00-00 | No | No | Current |