Home NDC 58458-002 Azacitidine
Product NDC 58458-002
11-digit product format 584580002
Labeler code 58458
Product ID 58458-002_36422686-af0f-a4e1-e063-6294a90a1b44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azacitidine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Reliance Life Sciences Private Limited
Application ANDA217453
Marketing category ANDA
Marketing start 2025-07-30
Substance AZACITIDINE
Active strength 100 mg/1
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
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 A217453-001 AZACITIDINE AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2025-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217453-001 AP
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 A217453-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2025-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217453-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2025-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217453-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2025-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217453-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2025-05-20 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217453-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2025-05-20 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Azacitidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZACITIDINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M801H13NRU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485246 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 58458-002-02 Azacitidine 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 58458-002-02 Azacitidine 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 1
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 58458-002-02 58458000202 1 VIAL, GLASS in 1 CARTON (58458-002-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS 2025-07-30 No No Current