What is NDC 69452-338?

69452-338 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, orally disintegrating, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Bionpharma Inc., NDC labeler code 69452. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Aripiprazole NDC 69452-338 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-338Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0338Add 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
69452-338-13	6945203381369452033813	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-338-13)Marketed from Feb 7, 2022

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, Orally disintegrating
Route: Oral
Labeler: Bionpharma Inc.NDC labeler code 69452
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202547
Marketing start: Feb 7, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 69452-338_a104bd7b-2748-450c-b4d3-9e96ccf2939dSPL ID a104bd7b-2748-450c-b4d3-9e96ccf2939dSPL set ID 720bc395-777d-4e5d-9571-aad5827dbf6dRxCUI 643019, 643022UNII 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

N469452033813 followed by a unit qualifier and the quantity

Package 69452-0338-13. 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 19, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Aripiprazole orally disintegrating 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 orally disintegrating tablets are 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) 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.

Full label on DailyMed (opens in a new tab)

About NDC 69452-338

What is NDC 69452-338?: 69452-338 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, orally disintegrating, listed with the FDA by Bionpharma Inc.. 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?: Bionpharma Inc., NDC labeler code 69452. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Aripiprazole NDCs
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

All 255 Aripiprazole NDCs

Other NDCs under ANDA 202547

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

FDA NDC Directory listings under ANDA 202547
Product	Strength	Form · route	Labeler	Product NDC
Aripiprazole	Aripiprazole 15 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-339