Home NDC 0143-9533 Allopurinol sodium
Product NDC 0143-9533
11-digit product format 001439533
Labeler code 0143
Product ID 0143-9533_5f7a1da9-2b25-46d2-8b6b-fdb44a4e1fd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Allopurinol sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076870
Marketing category ANDA
Marketing start 2004-09-01
Substance ALLOPURINOL SODIUM
Active strength 500 mg/25mL
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase 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 1 .
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 A076870-001 ALLOPURINOL SODIUM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076870-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076870-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2004-08-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Allopurinol sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLOPURINOL SODIUM 500 mg/25mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 428673RC2Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 252931 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 0143-9533-01 Allopurinol sodium 1 in 1 BOX, UNIT-DOSE INJECTION, POWDER, LYOPHILIZED, 1 5 0143-9533-01 Allopurinol sodium 25 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 25 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9533 ALLOPURINOL SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20220505_9ae58f3c-dbf9-4c10-9b79-233b10e0e9f1.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 0143-9533-01 00143953301 1 VIAL in 1 BOX, UNIT-DOSE (0143-9533-01) / 25 mL in 1 VIAL 1 vial 2004-09-01 0000-00-00 No No Current