Home NDC 67046-1514 Allopurinol
Product NDC 67046-1514
11-digit product format 670461514
Labeler code 67046
Product ID 67046-1514_2d6cdaf0-8651-d103-e063-6394a90a9352
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name allopurinol
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application NDA016084
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-02-05
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016084-001 ZYLOPRIM ALLOPURINOL 100MG TABLET / ORAL AB RLD, Approved before 1982 N016084-002 ZYLOPRIM ALLOPURINOL 300MG TABLET / ORAL AB RLD, Approved before 1982 N016084-003 ZYLOPRIM ALLOPURINOL 200MG TABLET / ORAL AB RLD 2022-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 115 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 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 101 observed states.
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 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 67046-1514-3 Allopurinol 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-1514 ALLOPURINOL TABLET [COUPLER LLC] 1 Current NDC, 1 package rows 20250207_2d6ce57f-a9df-319e-e063-6394a90ac93f.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 Units Marketing start Sample Exclude flag Status 67046-1514-3 67046151403 30 TABLET in 1 BLISTER PACK (67046-1514-3) 30 tablet 2025-02-05 No No Current