Home NDC 55111-654 Sirolimus
Product NDC 55111-654
11-digit product format 551110654
Labeler code 55111
Product ID 55111-654_f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sirolimus
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA201578
Marketing category ANDA
Marketing start 2014-10-27
Substance SIROLIMUS
Active strength 2 mg/1
Pharmacologic classes Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201578-001 SIROLIMUS SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 A201578-002 SIROLIMUS SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 3 · 84 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 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201578-001 SIROLIMUS 1MG TABLET / ORAL AB 2014-10-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201578-002 SIROLIMUS 2MG TABLET / ORAL AB 2014-10-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sirolimus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIROLIMUS 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W36ZG6FT64 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349208 Internal RxNorm lookup 360110 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 55111-654-01 Sirolimus 100 in 1 BOTTLE TABLET 100 17 55111-654-30 Sirolimus 30 in 1 BOTTLE TABLET 30 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-654 SIROLIMUS TABLET [DR. REDDY'S LABORATORIES LIMITED] 17 Current NDC, Legacy NDC, 2 package rows 20240530_2e6130e5-fa94-dcf8-605c-817bf396e93d.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sirolimus SIROLIMUS REMEDYREPACK INC. fc81cb86-61e1-4622-b2ce-cde263143aa0 2026-07-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201578 application number: ANDA201578 Sirolimus SIROLIMUS AvPAK 6a85ad01-8144-4d9c-e053-2991aa0a4f85 2026-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201578 application number: ANDA201578 Sirolimus SIROLIMUS American Health Packaging 5df60452-2b16-4ce9-8c29-48798a59d718 2025-08-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201578 application number: ANDA201578 Sirolimus SIROLIMUS Dr. Reddy's Laboratories Limited 2e6130e5-fa94-dcf8-605c-817bf396e93d 2023-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201578 application number: ANDA201578 ndc (product): 55111-654
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 55111-654-01 55111065401 100 TABLET in 1 BOTTLE (55111-654-01) 100 tablet 2014-10-27 0000-00-00 No No Current 55111-654-30 55111065430 30 TABLET in 1 BOTTLE (55111-654-30) 30 tablet 2014-10-27 0000-00-00 No No Current