Home NDC 27808-002 Risperidone
Product NDC 27808-002
11-digit product format 278080002
Labeler code 27808
Product ID 27808-002_0cc8cb14-5af8-475e-add9-f6cd3e9d7a38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form SOLUTION
Route ORAL
Labeler Cranbury Pharmaceuticals, LLC
Application ANDA079059
Marketing category ANDA
Marketing start 2015-03-13
Substance RISPERIDONE
Active strength 1 mg/mL
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079059-001 RISPERIDONE RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079059-001 AA
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079059-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2012-12-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Risperidone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISPERIDONE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L6UH7ZF8HC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199387 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 27808-002-01 Risperidone 30 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 30 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27808-002 RISPERIDONE SOLUTION [CRANBURY PHARMACEUTICALS, LLC] 18 Current NDC, Legacy NDC, 1 package rows 20250224_a0a21bec-68f0-444e-a611-d0602859410c.zip
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Risperidone RISPERIDONE ATLANTIC BIOLOGICALS CORP. dc8c6638-f487-49df-a265-78caa93e43d8 2026-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079059 application number: ANDA079059 Risperidone RISPERIDONE REMEDYREPACK INC. 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079059 application number: ANDA079059 Risperidone RISPERIDONE Bryant Ranch Prepack 4604052d-dbda-4535-b7b8-1bd72a129aca 2025-07-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079059 application number: ANDA079059 Risperidone RISPERIDONE Cranbury Pharmaceuticals, LLC a0a21bec-68f0-444e-a611-d0602859410c 2025-05-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079059 application number: ANDA079059 ndc (product): 27808-002 Risperidone RISPERIDONE Bryant Ranch Prepack 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 2025-03-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079059 application number: ANDA079059
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27808-002-01 27808000201 30 mL in 1 BOTTLE, UNIT-DOSE (27808-002-01) 30 ml 2015-03-13 0000-00-00 No No Current