DROXIA

Product NDC: 80725-830
11-digit product format: 807250830
Labeler code: 80725
Product ID: 80725-830_3feae4e9-790a-41c7-94df-6baf3ec503ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyurea
Dosage form: CAPSULE
Route: ORAL
Labeler: Waylis Therapeutics LLC
Application: NDA016295
Marketing category: NDA
Marketing start: 2025-09-11
Substance: HYDROXYUREA
Active strength: 300 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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016295-001	HYDREA	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982
N016295-002	DROXIA	HYDROXYUREA	200MG	CAPSULE / ORAL		RLD	1998-02-25
N016295-003	DROXIA	HYDROXYUREA	300MG	CAPSULE / ORAL		RLD	1998-02-25
N016295-004	DROXIA	HYDROXYUREA	400MG	CAPSULE / ORAL		RLD	1998-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016295-001	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 5 · 176 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
2026-10-15 13:18:30	2026-09	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N016295-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016295-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016295-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016295-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: DROXIA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYUREA	300 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200342	Internal RxNorm lookup
200343	Internal RxNorm lookup
200344	Internal RxNorm lookup
213282	Internal RxNorm lookup
213283	Internal RxNorm lookup
213284	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4ad13dc6-a2ab-4308-96b3-7c642c92cc23	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80725-830-60	DROXIA	60 in 1 BOTTLE	CAPSULE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80725-830-60	EA - Each	80725-830	ffbe954f-ddc1-45b2-83ff-7b323f83802e	1	2025-10-14

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDREA	HYDROXYUREA	H2-Pharma LLC	6053c775-68de-45e4-9af9-33b18fd0e140	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295
DROXIA	HYDROXYUREA	H2-Pharma LLC	a9494409-3571-4a81-9ad3-15ef7cb636a2	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295
HYDREA	HYDROXYUREA	Waylis Therapeutics LLC	8d41152f-a98a-4abc-afdf-a909012434a0	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295
DROXIA	HYDROXYUREA	Waylis Therapeutics LLC	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295 ndc (product): 80725-830

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
213282	Droxia 200 MG Oral Capsule	PSN	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213283	Droxia 300 MG Oral Capsule	PSN	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213284	Droxia 400 MG Oral Capsule	PSN	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
200342	hydroxyurea 200 MG Oral Capsule	PSN	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
200343	hydroxyurea 300 MG Oral Capsule	PSN	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
200344	hydroxyurea 400 MG Oral Capsule	PSN	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213282	hydroxyurea 200 MG Oral Capsule [Droxia]	SBD	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213283	hydroxyurea 300 MG Oral Capsule [Droxia]	SBD	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213284	hydroxyurea 400 MG Oral Capsule [Droxia]	SBD	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
200342	hydroxyurea 200 MG Oral Capsule	SCD	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
200343	hydroxyurea 300 MG Oral Capsule	SCD	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
200344	hydroxyurea 400 MG Oral Capsule	SCD	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213282	Droxia 200 MG Oral Capsule	SY	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213283	Droxia 300 MG Oral Capsule	SY	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1
213284	Droxia 400 MG Oral Capsule	SY	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80725-830-60	80725083060	60 CAPSULE in 1 BOTTLE (80725-830-60)	60 capsule	2025-09-11	No	No	Current