NDC codes

FDA NDC Directory
Product NDC (as listed)46708-256Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0256Add 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
46708-256-104670802561046708025610100 TABLET in 1 CARTON (46708-256-10)Marketed from Apr 28, 2015
46708-256-30467080256304670802563030 TABLET in 1 BOTTLE (46708-256-30)Marketed from Apr 28, 2015
46708-256-314670802563146708025631100 TABLET in 1 BOTTLE (46708-256-31)Marketed from Apr 28, 2015
46708-256-714670802567146708025671500 TABLET in 1 BOTTLE (46708-256-71)Marketed from Apr 28, 2015
46708-256-9146708025691467080256911000 TABLET in 1 BOTTLE (46708-256-91)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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202101
Marketing start
Listing expires
Identifiers
Product ID 46708-256_5108607e-5633-4b19-82f9-6c48720960c4SPL ID 5108607e-5633-4b19-82f9-6c48720960c4SPL set ID 793fc904-2f11-4f97-a0ac-4d6910cac0f9RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0346708258306, 0346708256302, 0346708254308, 0346708259303, 0346708255305
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

N446708025610 followed by a unit qualifier and the quantity

Package 46708-0256-10. 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 is indicated for the treatment of: •Schizophrenia [see CLINICAL STUDIES (14.1)] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is an atypical antipsychotic indicated as oral formulations for the: •Schizophrenia (14.1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-256

What is NDC 46708-256?
46708-256 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, listed with the FDA by Alembic 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?
Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 202101

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

FDA NDC Directory listings under ANDA 202101
ProductStrengthForm · routeLabelerProduct NDC
AripiprazoleAripiprazole 2 mg/1TabletOralAlembic Pharmaceuticals Limited46708-254
AripiprazoleAripiprazole 5 mg/1TabletOralAlembic Pharmaceuticals Limited46708-255
AripiprazoleAripiprazole 15 mg/1TabletOralAlembic Pharmaceuticals Limited46708-257
AripiprazoleAripiprazole 20 mg/1TabletOralAlembic Pharmaceuticals Limited46708-258
AripiprazoleAripiprazole 30 mg/1TabletOralAlembic Pharmaceuticals Limited46708-259
AripiprazoleAripiprazole 2 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-097
AripiprazoleAripiprazole 5 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-098
AripiprazoleAripiprazole 10 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-099
AripiprazoleAripiprazole 15 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-100
AripiprazoleAripiprazole 20 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-101
AripiprazoleAripiprazole 30 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-102
AripiprazoleAripiprazole 10 mg/1TabletOralCoupler LLC67046-0873
AripiprazoleAripiprazole 15 mg/1TabletOralCoupler LLC67046-1017
AripiprazoleAripiprazole 20 mg/1TabletOralCoupler LLC67046-1085
AripiprazoleAripiprazole 15 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8502
AripiprazoleAripiprazole 5 mg/1TabletOralREMEDYREPACK INC.70518-2150
AripiprazoleAripiprazole 10 mg/1TabletOralREMEDYREPACK INC.70518-2281

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