Home NDC 0781-3491-94 Azacitidine
Product NDC 0781-3491
Requested package NDC 0781-3491-94
11-digit product format 007813491
Labeler code 0781
Product ID 0781-3491_bf6cb4b7-d4ec-4124-862c-aaa6a32da511
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azacitidine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Sandoz Inc
Application ANDA212580
Marketing category ANDA
Marketing start 2024-05-16
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 A212580-001 AZACITIDINE AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212580-001 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 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212580-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2024-05-16 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 0781-3491-94 Azacitidine 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3491 AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 3 Current NDC, 1 package rows 20241025_7f89fcbd-d3f4-4112-8733-69baea41255e.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 Sample Exclude flag Status 0781-3491-94 00781349194 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3491-94) 2024-11-01 No No Current