Hydroxyurea

Product NDC: 10135-702
11-digit product format: 101350702
Labeler code: 10135
Product ID: 10135-702_d8383e21-6b7c-18c3-e053-2995a90a8401
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyurea
Dosage form: CAPSULE
Route: ORAL
Labeler: Marlex Pharmaceuticals, Inc.
Application: ANDA213438
Marketing category: ANDA
Marketing start: 2022-01-28
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10135-702		I	Inactivated by FDA		2026-08-17
excluded package	package	10135-702	10135-702-01	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-702-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-702-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-702-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-702-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-702-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-702-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-702-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-702-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-702-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A213438-001	HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE / ORAL	AB		2020-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213438-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213438-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	2020-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213438-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213438-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213438-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213438-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213438-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213438-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213438-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213438-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213438-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213438-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213438-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213438-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213438-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213438-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213438-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213438-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213438-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213438-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213438-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213438-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213438-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213438-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213438-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213438-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213438-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213438-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213438-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213438-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213438-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213438-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213438-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213438-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213438-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213438-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213438-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213438-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213438-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213438-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9be3ebe6-89e5-4e2f-8781-a389e7eb49e7	Product name	1	20250129
f76fb619-09b6-d149-3287-3661f7bc38cd	Product name	3	20250124
62a0eedf-9497-47af-bccf-d51b8b15b067	Product name	1	20180307

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-702-01	2025-01-30	C162847	48780-1	2cef2736-7129-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use. Initial U.S. Approval: 1967.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-702-01	Hydroxyurea	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-702-01	EA - Each	10135-702	901aee17-31fb-4217-9f02-1d2859444079	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-702	HYDROXYUREA CAPSULE [MARLEX PHARMACEUTICALS, INC.]	2	Legacy NDC, 1 package rows	20231109_d8383e21-6b7b-18c3-e053-2995a90a8401.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYUREA	HYDROXYUREA	Golden State Medical Supply, Inc.	1b42f2b4-3880-e7a9-e063-6294a90a5fd0	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213438 application number: ANDA213438
HYDROXYUREA	HYDROXYUREA	Leading Pharma, LLC	4c4e1c2f-2143-44f3-8825-aeba42e755e4	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213438 application number: ANDA213438

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197797	hydroxyurea 500 MG Oral Capsule	PSN	d8383e21-6b7b-18c3-e053-2995a90a8401	2
197797	hydroxyurea 500 MG Oral Capsule	SCD	d8383e21-6b7b-18c3-e053-2995a90a8401	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-702-01	10135070201	100 CAPSULE in 1 BOTTLE, PLASTIC (10135-702-01)	100 capsule	2022-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyurea - Marlex Pharmaceuticals, Inc.	Marlex Pharmaceuticals, Inc.	2023-11-08	HUMAN PRESCRIPTION DRUG LABEL	2