NDC 0003-0830

HYDREA

Hydroxyurea

HYDREA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Hydroxyurea.

• Product ID: 0003-0830_1fbe7104-4379-41be-bdc6-bf79d108a77b
• NDC: 0003-0830
• Product Type: Human Prescription Drug
• Proprietary Name: HYDREA
• Generic Name: Hydroxyurea
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA016295
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: HYDROXYUREA
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Antimetabolite [EPC],Urea [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0003-0830-50

100 CAPSULE in 1 BOTTLE (0003-0830-50)

• Marketing Start Date: 2009-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-0830-50 [00003083050]

HYDREA CAPSULE

• Marketing Category: NDA
• Application Number: NDA016295
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-01

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYUREA	500 mg/1

OpenFDA Data

• SPL SET ID: 050bd2a2-a125-721a-e366-255c5466f018
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • X6Q56QN5QC
• RxNorm Concept Unique ID - RxCUI:
  • 197797
  • 105602

Pharmacological Class

• Antimetabolite [EPC]
• Urea [CS]

NDC Crossover Matching brand name "HYDREA" or generic name "Hydroxyurea"

NDC	Brand Name	Generic Name
0003-0830	HYDREA	HYDROXYUREA
0003-6335	DROXIA	HYDROXYUREA
0003-6336	DROXIA	HYDROXYUREA
0003-6337	DROXIA	HYDROXYUREA
0093-0882	HYDROXYUREA	Hydroxyurea
0555-0882	HYDROXYUREA	Hydroxyurea
0904-6939	Hydroxyurea	Hydroxyurea
10135-702	Hydroxyurea	Hydroxyurea
24535-0831	Hydroxyurea	Hydroxyurea
42291-321	HYDROXYUREA	Hydroxyurea
49884-724	Hydroxyurea	Hydroxyurea
55154-3554	Hydroxyurea	Hydroxyurea
55154-7143	Hydroxyurea	Hydroxyurea