NDC 0904-6939

Hydroxyurea

Hydroxyurea

Hydroxyurea is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Hydroxyurea.

Product ID0904-6939_6517a45c-e82c-4f87-978c-6e3af451dd17
NDC0904-6939
Product TypeHuman Prescription Drug
Proprietary NameHydroxyurea
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1999-02-24
Marketing CategoryANDA / ANDA
Application NumberANDA075340
Labeler NameMajor Pharmaceuticals
Substance NameHYDROXYUREA
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite [EPC],Urea [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0904-6939-61

100 BLISTER PACK in 1 CARTON (0904-6939-61) > 1 CAPSULE in 1 BLISTER PACK
Marketing Start Date1999-02-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6939-61 [00904693961]

Hydroxyurea CAPSULE
Marketing CategoryANDA
Application NumberANDA075340
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-02-24

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA500 mg/1

OpenFDA Data

SPL SET ID:e76fd60e-7644-48c5-9857-3608a045000b
Manufacturer
UNII

Pharmacological Class

  • Antimetabolite [EPC]
  • Urea [CS]
  • Antimetabolite [EPC]
  • Urea [CS]

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

NDCBrand NameGeneric Name
0093-0882HYDROXYUREAHydroxyurea
0555-0882HYDROXYUREAHydroxyurea
0904-6939HydroxyureaHydroxyurea
10135-702HydroxyureaHydroxyurea
24535-0831HydroxyureaHydroxyurea
42291-321HYDROXYUREAHydroxyurea
49884-724HydroxyureaHydroxyurea
55154-3554HydroxyureaHydroxyurea
55154-7143HydroxyureaHydroxyurea
68084-284HydroxyureaHydroxyurea
70518-0916HydroxyureaHydroxyurea
60429-265HydroxyureaHydroxyurea
69315-164HYDROXYUREAHYDROXYUREA
0003-6335DROXIAHYDROXYUREA
0003-6336DROXIAHYDROXYUREA
0003-6337DROXIAHYDROXYUREA
0003-0830HYDREAHYDROXYUREA

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