Prescription drug · ANDA
Aripiprazole NDC 33342-122
Aripiprazole 2 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-122-07 | 33342012207 | 30 TABLET in 1 BOTTLE (33342-122-07)Marketed from Oct 8, 2016 | |
| 33342-122-11 | 33342012211 | 100 TABLET in 1 BOTTLE (33342-122-11)Marketed from Oct 8, 2016 | |
| 33342-122-12 | 33342012212 | 10 BLISTER PACK in 1 CARTON (33342-122-12) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 8, 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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204111
- Marketing start
- Listing expires
- Identifiers
- Product ID 33342-122_deb9183f-bf62-4547-9c33-b6d8af55ddd9SPL ID deb9183f-bf62-4547-9c33-b6d8af55ddd9SPL set ID ab4245a1-71f7-45be-a2ef-b0636ed3cc20RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0333342126078, 0333342123077, 0333342125071, 0333342122070, 0333342124074, 0333342127075
- 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
N433342012207followed by a unit qualifier and the quantityPackage 33342-0122-07. 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 Tablets are indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. Aripiprazole is indicated for: • Schizophrenia ( 14.1 ) • Irritability Associated with Autistic Disorder ( 14.4 ) • Treatment of Tourette’s disorder ( 14.5 )
Excerpt only. Read the full label for complete information.
About NDC 33342-122
- What is NDC 33342-122?
- 33342-122 is the product NDC for Aripiprazole, Aripiprazole 2 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, 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?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?
- 256 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 15 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-515 | 59651-0515-0359651-0515-30 |
Other NDCs under ANDA 204111
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 | Macleods Pharmaceuticals Limited | 33342-124 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-123 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-127 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-125 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-126 |