What is NDC 0480-1453?

0480-1453 is the product NDC for Risperidone kit, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Risperidone?

168 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Risperidone NDC 0480-1453 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-1453Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-1453Add 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
0480-1453-08	0048014530800480145308	1 KIT in 1 CARTON (0480-1453-08) * 2 mL in 1 VIAL (0480-9735-01) * 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.NDC labeler code 0480
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 0480-1453_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

N400480145308 followed by a unit qualifier and the quantity

Package 00480-1453-08. 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)

About NDC 0480-1453

What is NDC 0480-1453?: 0480-1453 is the product NDC for Risperidone kit, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Risperidone.
Who is the labeler?: Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Risperidone?: 168 other product NDCs are listed under this name. See all Risperidone 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 Risperidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-013	87564-0013-28
Risperidone	Risperidone 1 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-014	87564-0014-28
Risperidone	Risperidone 2 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-015	87564-0015-28
Risperidone	Risperidone 3 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-016	87564-0016-28
Risperidone	Risperidone 4 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-017	87564-0017-28
Risperidone	Risperidone .5 mg/1	TabletOral	Coupler LLC	67046-0644	67046-0644-03
Risperidone	Risperidone .25 mg/1	TabletOral	Coupler LLC	67046-2064	67046-2064-03
Risperidone	Risperidone 1 mg/1	TabletOral	Coupler LLC	67046-0635	67046-0635-03
Risperidone	Risperidone 2 mg/1	TabletOral	Coupler LLC	67046-0630	67046-0630-03
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amici Pharma, Inc.	69292-571	69292-0571-30

All 169 Risperidone NDCs

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.	0480-1232
Risperidone	—	Kit	Teva Pharmaceuticals, Inc.	0480-1342
Risperidone	—	Kit	Teva Pharmaceuticals, Inc.	0480-1554