Home NDC 42291-321 HYDROXYUREA
Product NDC 42291-321
11-digit product format 422910321
Labeler code 42291
Product ID 42291-321_4133de1c-b333-3b84-e063-6294a90a2432
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyurea
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA075143
Marketing category ANDA
Marketing start 2013-07-23
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075143-001 HYDROXYUREA HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 A075143-002 HYDROXYUREA HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075143-001 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 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 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075143-001 HYDROXYUREA 500MG CAPSULE / ORAL AB 1998-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075143-002 HYDROXYUREA 250MG CAPSULE / ORAL 2000-09-21 bb7c543d1eb4…
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 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 42291-321-01 HYDROXYUREA 100 in 1 BOTTLE CAPSULE 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYUREA ACTIVE INGREDIENT X6Q56QN5QC HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 HYDROXYUREA ACTIVE MOIETY X6Q56QN5QC HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 EDETATE CALCIUM DISODIUM INACTIVE INGREDIENT 25IH6R4SGF HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 PROPYLPARABEN SODIUM INACTIVE INGREDIENT 625NNB0G9N HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-321 HYDROXYUREA CAPSULE [AVKARE] 8 Current NDC, Legacy NDC, 1 package rows 20220114_862583ff-6d5c-3f7d-e3bd-352fb0400928.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 Marketing end Sample Exclude flag Status 42291-321-01 42291032101 100 CAPSULE in 1 BOTTLE (42291-321-01) 100 capsule 2013-07-23 0000-00-00 No No Current