Risperidone NDC 0480-1342

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-1342Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-1342Add 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
0480-1342-08	00480134208	1 KIT in 1 CARTON (0480-1342-08) * 2 mL in 1 VIAL (0480-9734-01) * 2 mL in 1 SYRINGE (0480-1200-21)Marketed from Dec 11, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Risperidone
Generic name (nonproprietary): risperidone
Dosage form: Kit
Labeler: Teva Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214068
Marketing start: Dec 11, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 0480-1342_7cf4d36f-baab-4a9e-8a17-aeb0d6dd7918SPL ID 7cf4d36f-baab-4a9e-8a17-aeb0d6dd7918SPL set ID 32c0f081-b418-4c1c-b39e-eb5c344043c7RxCUI 402010, 402011, 402012, 706822

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400480134208 followed by a unit qualifier and the quantity

Package 00480-1342-08. 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 Feb 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: for the treatment of schizophrenia. ( 1.1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. ( 1.2 ) 1.1 Schizophrenia Risperidone for Extended-Release Injectable Suspension is indicated for the treatment of schizophrenia [see Clinical Studies ( 14.1 )] . 1.2 Bipolar Disorder Risperidone for Extended-Release Injectable Suspension is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder [see Clinical Studies ( 14.2 , 14.3 )] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214068

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

FDA NDC Directory listings under ANDA 214068
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	—	Kit	Teva Pharmaceuticals, Inc.	0480-1453
Risperidone	—	Kit	Teva Pharmaceuticals, Inc.	0480-1554
Risperidone	—	Kit	Teva Pharmaceuticals, Inc.	0480-1232