Prescription drug · ANDA
Aripiprazole NDC 76282-046
Aripiprazole 10 mg/1 · Tablet · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-046-01 | 76282004601 | 100 TABLET in 1 BOTTLE (76282-046-01)Marketed from Oct 7, 2016 | |
| 76282-046-30 | 76282004630 | 30 TABLET in 1 BOTTLE (76282-046-30)Marketed from Oct 7, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Aripiprazole
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205064
- Marketing start
- Listing expires
- Identifiers
- Product ID 76282-046_ae9e2824-8741-4973-b349-a18ce05cb334SPL ID ae9e2824-8741-4973-b349-a18ce05cb334SPL set ID 705190bf-9f9d-4183-a56b-4eeafeacde59RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476282004601followed by a unit qualifier and the quantityPackage 76282-0046-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Aripiprazole oral tablets are indicated for the treatment of: • Schizophrenia [see CLINICAL STUDIES ( 14.1 )] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for: •Schizophrenia ( 14.1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205064
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3850 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3848 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-044 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-819 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-048 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-827 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-045 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-820 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-047 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-049 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-828 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-829 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-830 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | NorthStar RxLLC | 16714-141 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | NorthStar RxLLC | 16714-145 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3906 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | NorthStar RxLLC | 16714-142 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | NorthStar RxLLC | 16714-143 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | NorthStar RxLLC | 16714-144 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | NorthStar RxLLC | 16714-146 |
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