Prescription drug · ANDA
Aripiprazole NDC 70518-2820
Aripiprazole 10 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2820-0 | 70518282000 | 30 TABLET in 1 BLISTER PACK (70518-2820-0)Marketed from Jul 27, 2020 | |
| 70518-2820-3 | 70518282003 | 30 TABLET in 1 BLISTER PACK (70518-2820-3)Marketed from Dec 23, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207105
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-2820_57c28467-86ee-6136-e063-6394a90ab436SPL ID 57c28467-86ee-6136-e063-6394a90ab436SPL set ID f713c38e-cc49-4243-96b9-32d5dbbcf9cbRxCUI 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
N470518282000followed by a unit qualifier and the quantityPackage 70518-2820-00. 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 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole tablets are an atypical antipsychotic. Aripiprazole tablets are indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) 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 70518-2820
- What is NDC 70518-2820?
- 70518-2820 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 2 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 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 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2806 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2869 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2897 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2974 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-430 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-431 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-432 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-433 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-434 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-435 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8089 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3090 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1832 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Coupler LLC | 67046-0492 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4665 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Direct_Rx | 72189-466 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Direct_Rx | 72189-476 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1903 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-4863 |
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