Home NDC 70121-2628 Risperidone
Product NDC 70121-2628
11-digit product format 701212628
Labeler code 70121
Product ID 70121-2628_88f28969-3a2c-4851-ab01-18be48a87355
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form KIT
Route INTRAMUSCULAR
Labeler Amneal Pharmaceuticals LLC
Application ANDA218586
Marketing category ANDA
Marketing start 2025-09-08
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218586-001 RISPERIDONE RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A218586-002 RISPERIDONE RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A218586-003 RISPERIDONE RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A218586-004 RISPERIDONE RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 A218586-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218586-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218586-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218586-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218586-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218586-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218586-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218586-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218586-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218586-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218586-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218586-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…
Observed Orange Book normalized TE 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402010 Internal RxNorm lookup 402011 Internal RxNorm lookup 402012 Internal RxNorm lookup 706822 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 70121-1353-1 Risperidone 2 mL in 1 VIAL INJECTION, POWDER, FOR SUSPENSIO 2 mL 50 mg in 2mL 6 70121-2628-5 Risperidone 1 in 1 CARTON KIT 1 6
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 70121-1353-1 70121135301 2 mL in 1 VIAL 2 ml Historical 70121-2628-5 70121262805 1 KIT in 1 CARTON (70121-2628-5) * 2 mL in 1 VIAL (70121-1353-1) * 2 mL in 1 SYRINGE (70121-2624-2) 1 kit 2025-09-08 No No Current