Home NDC 16571-806 Sirolimus
Product NDC 16571-806
11-digit product format 165710806
Labeler code 16571
Product ID 16571-806_fff39157-a122-4e42-90f3-42d21ca85532
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sirolimus
Dosage form SOLUTION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA215116
Marketing category ANDA
Marketing start 2025-07-15
Substance SIROLIMUS
Active strength 1 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215116-001 SIROLIMUS SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2025-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215116-001 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.
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 A215116-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2025-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215116-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2025-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215116-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2025-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215116-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2025-07-15 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215116-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2025-07-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sirolimus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIROLIMUS 1 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314230 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 16571-806-06 Sirolimus 1 in 1 CARTON SOLUTION 1 5 16571-806-06 Sirolimus 1 in 1 KIT SOLUTION 1 5
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 16571-806-06 16571080606 1 CARTON in 1 KIT (16571-806-06) / 1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS 1 carton 2025-07-15 No No Current