What is NDC 46708-261?

46708-261 is the product NDC for Aripiprazole, Aripiprazole 15 mg/1 tablet, orally disintegrating, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Aripiprazole NDC 46708-261 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-261Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0261Add 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
46708-261-10	4670802611046708026110	30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (46708-261-10)Marketed from May 21, 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 — 15 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202102
Marketing start: May 21, 2015
Listing expires: Dec 31, 2027
Identifiers: Product ID 46708-261_1ea06df8-17dc-46eb-921a-2b52d41ea622SPL ID 1ea06df8-17dc-46eb-921a-2b52d41ea622SPL set ID 4f1691a8-724e-430d-9bab-27b59ef9bd4eRxCUI 643019, 643022UNII 82VFR53I78UPC 0346708261108, 0346708260101
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

N446708026110 followed by a unit qualifier and the quantity

Package 46708-0261-10. 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 Jan 27, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Aripiprazole Orally Disintegrating Tablets are 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 46708-261

What is NDC 46708-261?: 46708-261 is the product NDC for Aripiprazole, Aripiprazole 15 mg/1 tablet, orally disintegrating, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: 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
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 202102

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

FDA NDC Directory listings under ANDA 202102
Product	Strength	Form · route	Labeler	Product NDC
Aripiprazole	Aripiprazole 10 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-260
Aripiprazole	Aripiprazole 10 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-103
Aripiprazole	Aripiprazole 15 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-104