Home NDC 0143-9566 Azathioprine Sodium
Product NDC 0143-9566
11-digit product format 001439566
Labeler code 0143
Product ID 0143-9566_0d7e1bc4-3059-47a8-9331-2f37bb3c7b4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azathioprine Sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074419
Marketing category ANDA
Marketing start 1995-05-01
Substance AZATHIOPRINE SODIUM
Active strength 100 mg/10mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]
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 43 .
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 A074419-001 AZATHIOPRINE SODIUM AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31
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 2 · 43 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 2026-09-14 22:38:34 2026-08 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074419-001 AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION RS 1995-03-31 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Azathioprine Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZATHIOPRINE SODIUM 100 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AM94R510MS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239983 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 0143-9566-01 Azathioprine Sodium 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 9 0143-9566-01 Azathioprine Sodium 1 in 1 BOX, UNIT-DOSE INJECTION, POWDER, LYOPHILIZED, 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9566 AZATHIOPRINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250125_9ffe79a1-ac91-4a7b-a9e3-7c84bfa9ddf0.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 · 1 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 0143-9566-01 00143956601 1 VIAL in 1 BOX, UNIT-DOSE (0143-9566-01) / 10 mL in 1 VIAL 1 vial 1995-05-01 0000-00-00 No No Current