Aripiprazole NDC 46708-255

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-255Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0255Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
46708-255-10	46708025510	100 TABLET in 1 CARTON (46708-255-10)Marketed from Apr 28, 2015
46708-255-30	46708025530	30 TABLET in 1 BOTTLE (46708-255-30)Marketed from Apr 28, 2015
46708-255-31	46708025531	100 TABLET in 1 BOTTLE (46708-255-31)Marketed from Apr 28, 2015
46708-255-45	46708025545	180 TABLET in 1 BOTTLE (46708-255-45)Marketed from Apr 28, 2015
46708-255-60	46708025560	60 TABLET in 1 BOTTLE (46708-255-60)Marketed from Apr 28, 2015
46708-255-71	46708025571	500 TABLET in 1 BOTTLE (46708-255-71)Marketed from Apr 28, 2015
46708-255-91	46708025591	1000 TABLET in 1 BOTTLE (46708-255-91)Marketed from Apr 28, 2015

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202101
Marketing start: Apr 28, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 46708-255_5108607e-5633-4b19-82f9-6c48720960c4SPL ID 5108607e-5633-4b19-82f9-6c48720960c4SPL set ID 793fc904-2f11-4f97-a0ac-4d6910cac0f9RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0346708258306, 0346708256302, 0346708254308, 0346708259303, 0346708255305
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

N446708025510 followed by a unit qualifier and the quantity

Package 46708-0255-10. 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 Jan 27, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Aripiprazole is 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 is an atypical antipsychotic indicated as oral formulations for the: •Schizophrenia (14.1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202101

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202101
Product	Strength	Form · route	Labeler	Product NDC
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-2150
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-102
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-099
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-100
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-101
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8502
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-254
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-257
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-256
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-258
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-259
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-2281
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Coupler LLC	67046-0873
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Coupler LLC	67046-1017
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	Coupler LLC	67046-1085
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-098
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-097