Prescription drug · ANDA
Aripiprazole NDC 72189-476
Aripiprazole 10 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-476-30 | 7218904763072189047630 | 30 TABLET in 1 BOTTLE (72189-476-30)Marketed from May 30, 2023 |
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
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207105
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-476_2c4e05d7-5e1f-f566-e063-6294a90acadaSPL ID 2c4e05d7-5e1f-f566-e063-6294a90acadaSPL set ID fcea91c3-e428-8991-e053-6394a90a099dRxCUI 349545UNII 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
N472189047630followed by a unit qualifier and the quantityPackage 72189-0476-30. 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)] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see CLINICAL STUDIES (14.2)] Adjunctive Treatment of Major Depressive Disorder [see CLINICAL STUDIES (14.3)] Irritability Associated with Autistic Disorder [see CLINICAL STUDIES (14.4)] Treatment of Tourette’s Disorder [see CLINICAL STUDIES (14.5)]
Excerpt only. Read the full label for complete information.
About NDC 72189-476
- What is NDC 72189-476?
- 72189-476 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aripiprazole.
- What is the active ingredient?
- Aripiprazole.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aripiprazole?
- 254 other product NDCs are listed under this name. See all Aripiprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aripiprazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4745 | 70518-4745-00 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Coupler LLC | 67046-0873 | 67046-0873-03 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1052 | 67046-1052-03 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 | 67046-2046-03 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-006 | 87441-0006-01 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Coupler LLC | 67046-1085 | 67046-1085-03 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Coupler LLC | 67046-0885 | 67046-0885-03 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-1017 | 67046-1017-03 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Coupler LLC | 67046-0492 | 67046-0492-03 |
| Aripiprazole | Aripiprazole 10 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-514 | 59651-0514-0359651-0514-30 |
Other NDCs under ANDA 207105
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 2 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3725 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Direct_Rx | 72189-466 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7733 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Coupler LLC | 67046-0885 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1903 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1052 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Prefferred Pharmaceuticals Inc. | 68788-7808 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1935 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2806 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2820 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2869 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2897 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1980 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1687 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2369 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2974 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4665 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8089 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3090 |
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