NDC codes

FDA NDC Directory
Product NDC (as listed)13668-216Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0216Add 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
13668-216-011366802160113668021601100 TABLET in 1 BOTTLE (13668-216-01)Marketed from Apr 28, 2015
13668-216-051366802160513668021605500 TABLET in 1 BOTTLE (13668-216-05)Marketed from Apr 28, 2015
13668-216-30136680216301366802163030 TABLET in 1 BOTTLE (13668-216-30)Marketed from Apr 28, 2015
13668-216-6913668021669136680216696250 TABLET in 1 BOTTLE (13668-216-69)Marketed from Apr 28, 2015
13668-216-90136680216901366802169090 TABLET in 1 BOTTLE (13668-216-90)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 — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201519
Marketing start
Listing expires
Identifiers
Product ID 13668-216_264dc32a-9f5f-43be-96ee-0d30503de683SPL ID 264dc32a-9f5f-43be-96ee-0d30503de683SPL set ID 3988e66f-339c-451e-9f8a-9d0c0a2a381bRxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0313668218305, 0313668216301, 0313668221305, 0313668219302, 0313668217308, 0313668220308
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

N413668021601 followed by a unit qualifier and the quantity

Package 13668-0216-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Aripiprazole tablets are an atypical antipsychotic. Aripiprazole tablets are indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 ) Aripiprazole 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13668-216

What is NDC 13668-216?
13668-216 is the product NDC for aripiprazole, Aripiprazole 2 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 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?
Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 201519

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

FDA NDC Directory listings under ANDA 201519
ProductStrengthForm · routeLabelerProduct NDC
aripiprazoleAripiprazole 5 mg/1TabletOralMajor Pharmaceuticals0904-6656
aripiprazoleAripiprazole 5 mg/1TabletOralTorrent Pharmaceuticals Limited13668-217
aripiprazoleAripiprazole 10 mg/1TabletOralTorrent Pharmaceuticals Limited13668-218
aripiprazoleAripiprazole 15 mg/1TabletOralTorrent Pharmaceuticals Limited13668-219
aripiprazoleAripiprazole 20 mg/1TabletOralTorrent Pharmaceuticals Limited13668-220
aripiprazoleAripiprazole 30 mg/1TabletOralTorrent Pharmaceuticals Limited13668-221
aripiprazoleAripiprazole 5 mg/1TabletOralA-S Medication Solutions50090-6563
aripiprazoleAripiprazole 20 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-691
aripiprazoleAripiprazole 10 mg/1TabletOralBryant Ranch Prepack63629-7003
aripiprazoleAripiprazole 15 mg/1TabletOralBryant Ranch Prepack63629-7108
aripiprazoleAripiprazole 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7063
aripiprazoleAripiprazole 2 mg/1TabletOralREMEDYREPACK INC.70518-2584
aripiprazoleAripiprazole 15 mg/1TabletOralREMEDYREPACK INC.70518-2643
aripiprazoleAripiprazole 20 mg/1TabletOralBryant Ranch Prepack71335-0412
AripiprazoleAripiprazole 20 mg/1TabletOralDirect_Rx72189-455
aripiprazoleAripiprazole 5 mg/1TabletOralProficient Rx LP82804-235
aripiprazoleAripiprazole 10 mg/1TabletOralProficient Rx LP82804-236

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