HYDROXYUREA

Product NDC: 70518-3615
11-digit product format: 705183615
Labeler code: 70518
Product ID: 70518-3615_f1ffbc60-1388-2b82-e053-2995a90a9111
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYUREA
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA213438
Marketing category: ANDA
Marketing start: 2023-01-10
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: 2024-12-31
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	70518-3615		D	Discontinued by firm		2026-08-17
excluded package	package	70518-3615	70518-3615-0	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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3615-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3615-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3615	HYDROXYUREA CAPSULE [REMEDYREPACK INC.]	4	Legacy NDC	20241122_0dd79b2b-e0fa-4581-9c38-bf9a909ccb62.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3615-0	70518361500	30 CAPSULE in 1 BLISTER PACK (70518-3615-0)	30 capsule	2023-01-10	0000-00-00	No	No	Current