Home NDC 62135-516 Allopurinol
Product NDC 62135-516
11-digit product format 621350516
Labeler code 62135
Product ID 62135-516_4b432cc5-11c8-4450-e063-6394a90a1053
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Allopurinol
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA077353
Marketing category ANDA
Marketing start 2006-05-11
Substance ALLOPURINOL
Active strength 100 mg/1
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077353-001 ALLOPURINOL ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 A077353-002 ALLOPURINOL ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 84 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 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077353-001 ALLOPURINOL 100MG TABLET / ORAL AB 2005-09-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077353-002 ALLOPURINOL 300MG TABLET / ORAL AB 2005-09-08 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Allopurinol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLOPURINOL 100 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197319 Internal RxNorm lookup 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 62135-516-31 Allopurinol 300 in 1 BOTTLE TABLET 300 3 62135-516-90 Allopurinol 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-516 ALLOPURINOL TABLET [CHARTWELL RX, LLC] 2 Current NDC, 2 package rows 20241127_cdc3f33b-ff2b-4a84-a820-51a497fdf3d9.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 Sample Exclude flag Status 62135-516-31 62135051631 300 TABLET in 1 BOTTLE (62135-516-31) 300 tablet 2023-01-27 No No Current 62135-516-90 62135051690 90 TABLET in 1 BOTTLE (62135-516-90) 90 tablet 2023-01-27 No No Current