Home NDC 49884-724 Hydroxyurea
Product NDC 49884-724
11-digit product format 498840724
Labeler code 49884
Product ID 49884-724_4413d36e-3573-4ba9-9baa-c0bbd5e254d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyurea
Dosage form CAPSULE
Route ORAL
Labeler Par Health USA, LLC
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 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 · 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 49884-724-01 Hydroxyurea 100 in 1 BOTTLE CAPSULE 100 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYUREA ACTIVE INGREDIENT X6Q56QN5QC HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 HYDROXYUREA ACTIVE MOIETY X6Q56QN5QC HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] 7 HYDROXYUREA ACTIVE INGREDIENT X6Q56QN5QC HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 HYDROXYUREA ACTIVE MOIETY X6Q56QN5QC HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] 3 HYDROXYUREA ACTIVE INGREDIENT X6Q56QN5QC HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYDROXYUREA ACTIVE MOIETY X6Q56QN5QC HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-724 HYDROXYUREA CAPSULE [ENDO USA, INC.] 22 Current NDC, Legacy NDC, 1 package rows 20240926_9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6.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 49884-724-01 49884072401 100 CAPSULE in 1 BOTTLE (49884-724-01) 100 capsule 1999-02-24 0000-00-00 No No Current