Home NDC 67046-1619 HYDROXYUREA
Product NDC 67046-1619
11-digit product format 670461619
Labeler code 67046
Product ID 67046-1619_44fd4944-cb39-8ec8-e063-6394a90a8588
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROXYUREA
Dosage form CAPSULE
Route ORAL
Labeler Coupler LLC
Application ANDA218021
Marketing category ANDA
Marketing start 2025-12-02
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 A218021-001 HYDROXYUREA HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218021-001 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.
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 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218021-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 2024-03-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base HYDROXYUREA
Listing expiration 2026-12-31 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 67046-1619-3 HYDROXYUREA 30 in 1 BLISTER PACK CAPSULE 30 1
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 Sample Exclude flag Status 67046-1619-3 67046161903 30 CAPSULE in 1 BLISTER PACK (67046-1619-3) 30 capsule 2025-12-02 No No Current