Home NDC 67544-313 Allopurinol
Product NDC 67544-313
11-digit product format 675440313
Labeler code 67544
Product ID 67544-313_c5d95534-5585-40ff-9d6c-8b4a62c1b101
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Allopurinol
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA018877
Marketing category NDA
Marketing start 2009-04-06
Substance ALLOPURINOL
Active strength 300 mg/1
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 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 N018877-001 ALLOPURINOL ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018877-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018877-001 ALLOPURINOL 300MG TABLET / ORAL AB 1984-09-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Allopurinol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLOPURINOL 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63CZ7GJN5I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197320 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 67544-313-45 Allopurinol 45 in 1 BOTTLE, PLASTIC TABLET 45 1 67544-313-60 Allopurinol 90 in 1 BOTTLE, PLASTIC TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-313 ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 2 package rows 20221223_9b0e3f11-c02a-443d-806f-134c907ea371.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 · 4 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 67544-313-45 67544031345 45 TABLET in 1 BOTTLE, PLASTIC (67544-313-45) 45 tablet 2022-12-21 0000-00-00 No No Current 67544-313-60 67544031360 90 TABLET in 1 BOTTLE, PLASTIC (67544-313-60) 90 tablet 2022-12-21 0000-00-00 No No Current