NDC codes

FDA NDC Directory
Product NDC (as listed)69452-339Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0339Add 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 NDC11-digit (billing)PackageCopy
69452-339-13694520339136945203391330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-339-13)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 — 15 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
Listing expires
Identifiers
Product ID 69452-339_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

N469452033913 followed by a unit qualifier and the quantity

Package 69452-0339-13. 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 . 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 69452-339

What is NDC 69452-339?
69452-339 is the product NDC for Aripiprazole, Aripiprazole 15 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AripiprazoleAripiprazole 15 mg/1TabletOralREMEDYREPACK INC.70518-474570518-4745-00
AripiprazoleAripiprazole 10 mg/1TabletOralCoupler LLC67046-087367046-0873-03
AripiprazoleAripiprazole 2 mg/1TabletOralCoupler LLC67046-105267046-1052-03
AripiprazoleAripiprazole 15 mg/1TabletOralCoupler LLC67046-204667046-2046-03
AripiprazoleAripiprazole 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-00687441-0006-01
AripiprazoleAripiprazole 20 mg/1TabletOralCoupler LLC67046-108567046-1085-03
AripiprazoleAripiprazole 5 mg/1TabletOralCoupler LLC67046-088567046-0885-03
AripiprazoleAripiprazole 15 mg/1TabletOralCoupler LLC67046-101767046-1017-03
AripiprazoleAripiprazole 10 mg/1TabletOralCoupler LLC67046-049267046-0492-03
AripiprazoleAripiprazole 10 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited59651-51459651-0514-0359651-0514-30

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
ProductStrengthForm · routeLabelerProduct NDC
AripiprazoleAripiprazole 10 mg/1Tablet, Orally disintegratingOralBionpharma Inc.69452-338

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