HYDROXYUREA

Product NDC: 0555-0882
11-digit product format: 005550882
Labeler code: 0555
Product ID: 0555-0882_9d7feae3-66af-434e-b5dc-569e8ce56b80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyurea
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075143
Marketing category: ANDA
Marketing start: 1998-10-19
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

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 Identifiers#

Field, Values table
Field	Values
Unii	X6Q56QN5QC
Rxcui	197797

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
9be3ebe6-89e5-4e2f-8781-a389e7eb49e7	Product name	1	20250129
f76fb619-09b6-d149-3287-3661f7bc38cd	Product name	3	20250124
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
62a0eedf-9497-47af-bccf-d51b8b15b067	Product name	1	20180307
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0555-0882-02	HYDROXYUREA	100 in 1 BOTTLE	CAPSULE	100		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0882-02	EA - Each	0555-0882	6f1fc549-d5a5-4c38-9499-d4fdbdc5fd87	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYUREA	ACTIVE INGREDIENT	X6Q56QN5QC	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
HYDROXYUREA	ACTIVE MOIETY	X6Q56QN5QC	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]	8
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
HYDROXYUREA	ACTIVE INGREDIENT	X6Q56QN5QC	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYUREA	ACTIVE MOIETY	X6Q56QN5QC	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0882	HYDROXYUREA CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	20	Current NDC, Legacy NDC, 1 package rows	20240802_b9514ae5-79ae-4cc2-9d7f-c8f7806d1694.zip

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	b9514ae5-79ae-4cc2-9d7f-c8f7806d1694	20
197797	hydroxyurea 500 MG Oral Capsule	SCD	b9514ae5-79ae-4cc2-9d7f-c8f7806d1694	20
197797	hydroxyurea 500 MG Oral Capsule	PSN	862583ff-6d5c-3f7d-e3bd-352fb0400928	10
197797	hydroxyurea 500 MG Oral Capsule	SCD	862583ff-6d5c-3f7d-e3bd-352fb0400928	10
197797	hydroxyurea 500 MG Oral Capsule	PSN	7a2e2305-78bd-4077-96c6-59c5059201ab	2
197797	hydroxyurea 500 MG Oral Capsule	SCD	7a2e2305-78bd-4077-96c6-59c5059201ab	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-0882-02	00555088202	100 CAPSULE in 1 BOTTLE (0555-0882-02)	100 capsule	1998-10-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYUREA	AvKARE	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	10
HYDROXYUREA	Teva Pharmaceuticals USA, Inc.	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	20
HYDROXYUREA CAPSULES USP	Physicians Total Care, Inc.	2012-06-01	HUMAN PRESCRIPTION DRUG LABEL	2

HYDROXYUREA

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#