Aripiprazole (aripiprazole oral) NDC 72603-445

NDC codes

FDA NDC Directory

Product NDC (as listed)72603-445Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72603-0445Add 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	Copy
72603-445-01	72603044501	1 BOTTLE in 1 CARTON (72603-445-01) / 150 mL in 1 BOTTLEMarketed from May 1, 2024

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 oral
Active ingredients: Aripiprazole — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: NorthStar RxLLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216150
Marketing start: May 1, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 72603-445_15449fee-e073-7129-e063-6294a90a3538SPL ID 15449fee-e073-7129-e063-6294a90a3538SPL set ID 4a0a2f6c-d7bb-48d1-b5ca-066f27f78e41RxCUI 485496UNII 82VFR53I78UPC 0372603445015
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

N472603044501 followed by a unit qualifier and the quantity

Package 72603-0445-01. 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 Apr 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Aripiprazole oral solution is 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) ] • Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] • Treatment of Tourette’s Disorder [see Clinical Studies (14.5) ] Aripiprazole oral solution is an atypical antipsychotic. The oral formulations are indicated for: • Schizophrenia (14.1) • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2) • Irritability Associated with Autistic Disorder (14.4) • Treatment of Tourette’s disorder (14.5)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216150

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

FDA NDC Directory listings under ANDA 216150
Product	Strength	Form · route	Labeler	Product NDC
Aripiprazolearipiprazole oral	Aripiprazole 1 mg/mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-684
Aripiprazolearipiprazole oral	Aripiprazole 1 mg/mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0684