Home NDC 65841-771 sirolimus
Product NDC 65841-771
11-digit product format 658410771
Labeler code 65841
Product ID 65841-771_7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sirolimus
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA201676
Marketing category ANDA
Marketing start 2014-01-15
Substance SIROLIMUS
Active strength .5 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201676-001 SIROLIMUS SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 A201676-002 SIROLIMUS SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 A201676-003 SIROLIMUS SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 90 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 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201676-002 SIROLIMUS 2MG TABLET / ORAL AB 2023-02-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201676-003 SIROLIMUS 0.5MG TABLET / ORAL AB 2014-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201676-001 SIROLIMUS 1MG TABLET / ORAL AB 2023-02-15 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 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 .5 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349208 Internal RxNorm lookup 360110 Internal RxNorm lookup 905158 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 65841-771-01 sirolimus 100 in 1 BOTTLE TABLET, FILM COATED 100 11 65841-771-05 sirolimus 500 in 1 BOTTLE TABLET, FILM COATED 500 11 65841-771-06 sirolimus 30 in 1 BOTTLE TABLET, FILM COATED 30 11 65841-771-10 sirolimus 1000 in 1 BOTTLE TABLET, FILM COATED 1000 11 65841-771-16 sirolimus 90 in 1 BOTTLE TABLET, FILM COATED 90 11 65841-771-30 sirolimus 10 in 1 BLISTER PACK TABLET, FILM COATED 10 11 65841-771-77 sirolimus 10 in 1 CARTON TABLET, FILM COATED 10 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIROLIMUS ACTIVE INGREDIENT W36ZG6FT64 SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 SIROLIMUS ACTIVE MOIETY W36ZG6FT64 SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 GLYCERYL MONOOLEATE INACTIVE INGREDIENT 4PC054V79P SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65841-771 SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 11 Current NDC, Legacy NDC, 7 package rows 20230928_82562b68-224d-482a-b399-a89b81d5eb31.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.
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 65841-771-01 65841077101 100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01) 2014-01-15 0000-00-00 No No Current 65841-771-05 65841077105 500 TABLET, FILM COATED in 1 BOTTLE (65841-771-05) 2014-01-15 No No Current 65841-771-06 65841077106 30 TABLET, FILM COATED in 1 BOTTLE (65841-771-06) 2014-01-15 No No Current 65841-771-10 65841077110 1000 TABLET, FILM COATED in 1 BOTTLE (65841-771-10) 2014-01-15 No No Current 65841-771-16 65841077116 90 TABLET, FILM COATED in 1 BOTTLE (65841-771-16) 2014-01-15 No No Current 65841-771-30 65841077130 10 in 1 BLISTER PACK Historical 65841-771-77 65841077177 10 BLISTER PACK in 1 CARTON (65841-771-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-771-30) 10 blister pack 2014-01-15 No No Current