Home NDC 70748-272 risperidone
Product NDC 70748-272
11-digit product format 707480272
Labeler code 70748
Product ID 70748-272_295a5259-e2b6-4c5c-aacb-6a85a8c4babb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA211220
Marketing category ANDA
Marketing start 2025-10-17
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211220-001 RISPERIDONE RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A211220-002 RISPERIDONE RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A211220-003 RISPERIDONE RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A211220-001 CGT 2026-05-12 A211220-002 CGT 2026-05-09 A211220-003 CGT 2026-05-09
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211220-001 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211220-002 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211220-003 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base risperidone
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402010 Internal RxNorm lookup 402011 Internal RxNorm lookup 402012 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70748-272-13 risperidone 1 in 1 BOX KIT 1 4 70748-451-11 risperidone 2 mL in 1 VIAL INJECTION, POWDER, FOR SUSPENSIO 2 mL 50 mg in 2mL 4
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70748-272-13 70748027213 1 KIT in 1 BOX (70748-272-13) * 2 mL in 1 VIAL (70748-451-11) * 2 mL in 1 SYRINGE (70748-448-01) 1 kit 2025-10-17 No No Current 70748-451-11 70748045111 2 mL in 1 VIAL 2 ml Historical