Home NDC 16714-189 sirolimus
Product NDC 16714-189
11-digit product format 167140189
Labeler code 16714
Product ID 16714-189_433f1406-4cb9-4ae3-bdb9-2ff4c9011e5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sirolimus
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NORTHSTAR RX LLC
Application ANDA208691
Marketing category ANDA
Marketing start 2021-10-18
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 2027-12-31
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 A208691-001 SIROLIMUS SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 A208691-002 SIROLIMUS SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 A208691-003 SIROLIMUS SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16
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 · 111 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 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base sirolimus
Listing expiration 2027-12-31 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 · 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 16714-189-01 sirolimus 100 in 1 BOTTLE TABLET, FILM COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-189 SIROLIMUS TABLET, FILM COATED [NORTHSTAR RX LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240103_ad39eb60-1fa0-4722-8ba1-523194921c2a.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 Marketing start Marketing end Sample Exclude flag Status 16714-189-01 16714018901 100 TABLET, FILM COATED in 1 BOTTLE (16714-189-01) 2021-10-18 0000-00-00 No No Current