NDC codes

FDA NDC Directory
Product NDC (as listed)33342-122Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0122Add 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
33342-122-073334201220730 TABLET in 1 BOTTLE (33342-122-07)Marketed from Oct 8, 2016
33342-122-1133342012211100 TABLET in 1 BOTTLE (33342-122-11)Marketed from Oct 8, 2016
33342-122-123334201221210 BLISTER PACK in 1 CARTON (33342-122-12) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 8, 2016

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 — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204111
Marketing start
Listing expires
Identifiers
Product ID 33342-122_deb9183f-bf62-4547-9c33-b6d8af55ddd9SPL ID deb9183f-bf62-4547-9c33-b6d8af55ddd9SPL set ID ab4245a1-71f7-45be-a2ef-b0636ed3cc20RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0333342126078, 0333342123077, 0333342125071, 0333342122070, 0333342124074, 0333342127075
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

N433342012207 followed by a unit qualifier and the quantity

Package 33342-0122-07. 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 • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. Aripiprazole is indicated for: • Schizophrenia ( 14.1 ) • 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 33342-122

What is NDC 33342-122?
33342-122 is the product NDC for Aripiprazole, Aripiprazole 2 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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.

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 15 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited59651-51559651-0515-0359651-0515-30

All 257 Aripiprazole NDCs

Other NDCs under ANDA 204111

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

FDA NDC Directory listings under ANDA 204111
ProductStrengthForm · routeLabelerProduct NDC
AripiprazoleAripiprazole 10 mg/1TabletOralMacleods Pharmaceuticals Limited33342-124
AripiprazoleAripiprazole 5 mg/1TabletOralMacleods Pharmaceuticals Limited33342-123
AripiprazoleAripiprazole 30 mg/1TabletOralMacleods Pharmaceuticals Limited33342-127
AripiprazoleAripiprazole 15 mg/1TabletOralMacleods Pharmaceuticals Limited33342-125
AripiprazoleAripiprazole 20 mg/1TabletOralMacleods Pharmaceuticals Limited33342-126

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