Home NDC 67457-978 Aloprim
Product NDC 67457-978
11-digit product format 674570978
Labeler code 67457
Product ID 67457-978_4045f732-add9-4445-b4c8-a3a7f32bab46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Allopurinol
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application NDA020298
Marketing category NDA
Marketing start 2020-11-18
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 67457-978 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67457-978 67457-978-50 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 N020298-001 ALOPRIM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020298-001 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 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-978 ALOPRIM (ALLOPURINOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 4 Legacy NDC 20241004_018525b1-e37d-4ff2-9dc3-36b3d90ac3e0.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aloprim ALLOPURINOL Mylan Institutional LLC 10cc918f-aa44-415b-932d-2404695ac449 2022-02-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 020298 application number: NDA020298
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67457-978-50 67457097850 1 VIAL, GLASS in 1 CARTON (67457-978-50) > 25 mL in 1 VIAL, GLASS 2020-11-18 0000-00-00 No No Current