Home NDC 67877-746 Sirolimus
Product NDC 67877-746
11-digit product format 678770746
Labeler code 67877
Product ID 67877-746_b6349068-caf8-4f40-959d-cb9f1b8dd2be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sirolimus
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA214753
Marketing category ANDA
Marketing start 2021-03-13
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 A214753-001 SIROLIMUS SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 A214753-002 SIROLIMUS SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 A214753-003 SIROLIMUS SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12
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 · 105 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 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214753-002 SIROLIMUS 1MG TABLET / ORAL AB 2021-03-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214753-003 SIROLIMUS 2MG TABLET / ORAL AB 2021-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214753-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2021-03-12 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 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 67877-746-01 Sirolimus 100 in 1 BOTTLE TABLET, FILM COATED 100 8 67877-746-05 Sirolimus 500 in 1 BOTTLE TABLET, FILM COATED 500 8 67877-746-30 Sirolimus 30 in 1 BOTTLE TABLET, FILM COATED 30 8 67877-746-33 Sirolimus 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8 67877-746-38 Sirolimus 100 in 1 CARTON TABLET, FILM COATED 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-746 SIROLIMUS TABLET [ASCEND LABORATORIES, LLC] 6 Current NDC, Legacy NDC, 5 package rows 20230202_cdc49844-3e77-41d3-8287-b16d0c4742c5.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 · 3 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 67877-746-01 67877074601 100 TABLET, FILM COATED in 1 BOTTLE (67877-746-01) 2021-03-13 0000-00-00 No No Current 67877-746-05 67877074605 500 TABLET, FILM COATED in 1 BOTTLE (67877-746-05) 2021-03-13 0000-00-00 No No Current 67877-746-30 67877074630 30 TABLET, FILM COATED in 1 BOTTLE (67877-746-30) 2021-03-13 0000-00-00 No No Current 67877-746-33 67877074633 10 in 1 BLISTER PACK Historical 67877-746-38 67877074638 100 BLISTER PACK in 1 CARTON (67877-746-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-746-33) 100 blister pack 2021-03-13 0000-00-00 No No Current