Home NDC 68083-380 Allopurinol
Product NDC 68083-380
11-digit product format 680830380
Labeler code 68083
Product ID 68083-380_6a0eaf66-34ca-4ba5-a2c6-a3c369ddf30c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Allopurinol
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA212363
Marketing category ANDA
Marketing start 2022-01-26
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 A212363-001 ALLOPURINOL SODIUM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212363-001 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 2026-02-19 14:30 UTC 2026-02 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212363-001 ALLOPURINOL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212363-001 ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-01-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Allopurinol
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 68083-380-01 Allopurinol 25 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 25 6 68083-380-01 Allopurinol 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-380 ALLOPURINOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20220325_4839e842-511e-4c72-9153-2b7e4e1954e2.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68083-380-01 68083038001 1 VIAL, GLASS in 1 CARTON (68083-380-01) / 25 mL in 1 VIAL, GLASS 2022-01-26 0000-00-00 No No Current