Hydroxyurea

Product NDC: 55154-3554
Requested package NDC: 55154-3554-0
11-digit product format: 551543554
Labeler code: 55154
Product ID: 55154-3554_45132fa1-6697-41ae-8ab1-ab40161e215b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyurea
Dosage form: CAPSULE
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA075340
Marketing category: ANDA
Marketing start: 1999-02-24
Marketing end: 0000-00-00
Substance: HYDROXYUREA
Active strength: 500 mg/1
Pharmacologic classes: Antimetabolite [EPC], Urea [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55154-3554	55154-3554-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-3554	55154-3554-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075340-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075340-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075340-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075340-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075340-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075340-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075340-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075340-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075340-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075340-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075340-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075340-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075340-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075340-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075340-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075340-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075340-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075340-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075340-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075340-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075340-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075340-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075340-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075340-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075340-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075340-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075340-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075340-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075340-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075340-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075340-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075340-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075340-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075340-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075340-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075340-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075340-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075340-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075340-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075340-001	AB	1	`e64feba35796…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-3554	HYDROXYUREA CAPSULE [CARDINAL HEALTH 107, LLC]	3	Legacy NDC	20241025_45132fa1-6697-41ae-8ab1-ab40161e215b.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyurea	HYDROXYUREA	Major Pharmaceuticals	e76fd60e-7644-48c5-9857-3608a045000b	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075340 application number: ANDA075340
Hydroxyurea	HYDROXYUREA	Par Health USA, LLC	9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075340 application number: ANDA075340
Hydroxyurea	HYDROXYUREA	American Health Packaging	c84a2241-6c05-480f-8a5b-049e08c27d73	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075340 application number: ANDA075340

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X6Q56QN5QC	HYDROXYUREA	127-07-1	HYDROXYUREA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-3554-0	55154355400	10 BLISTER PACK in 1 BAG (55154-3554-0) > 1 CAPSULE in 1 BLISTER PACK	10 blister pack	1999-02-24	0000-00-00	No	No	Current