Home NDC 0904-6939 Hydroxyurea
Product NDC 0904-6939
11-digit product format 009046939
Labeler code 0904
Product ID 0904-6939_554e6427-7d26-4f99-b69b-10468b9bb014
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyurea
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA075340
Marketing category ANDA
Marketing start 1999-02-24
Substance HYDROXYUREA
Active strength 500 mg/1
Pharmacologic classes Antimetabolite [EPC], Urea [CS]
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 A075340-001 HYDROXYUREA HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075340-001 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 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075340-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1999-02-24 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 Hydroxyurea
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYUREA 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X6Q56QN5QC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197797 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 0904-6939-61 Hydroxyurea 100 in 1 CARTON CAPSULE 100 7 0904-6939-61 Hydroxyurea 1 in 1 BLISTER PACK CAPSULE 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6939 HYDROXYUREA CAPSULE [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20241018_e76fd60e-7644-48c5-9857-3608a045000b.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 · 3 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 0904-6939-61 00904693961 100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACK 100 blister pack 1999-02-24 0000-00-00 No No Current