Prescription Drug Information: Hydralazine Hydrochloride (Page 2 of 2)

HOW SUPPLIED

HydrALAZINE Hydrochloride Tablets, USP

10 mg — round, convex, pink film-coated tablet engraved with HP above 1 on one side and plain on the other side

Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6440-61

25 mg — round, convex, pink film-coated tablet engraved with HP above 2 on one side and plain on the other side

Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6441-61

50 mg — round, convex, pink film-coated tablet engraved with HP above 3 on one side and plain on the other side

Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6442-61

100 mg — round, convex, pink film-coated tablet engraved with HP above 4 on one side and plain on the other side

Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6443-61

Bottle of 1000 tablets, NDC 0904-6443-10

Dispense in a tight, light-resistant container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1-866-901-DRUG (3784)

logo
(click image for full-size original)

Distributed by:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152 USA

Refer to package label for Distributor’s NDC Number

51U000000172US05

Revised: 08/2021

Package/Label Display Panel

Hydralazine HCl Tablets, USP

10 mg

100 Tablets

Carton label
(click image for full-size original)

Package/Label Display Panel

Hydralazine HCl Tablets, USP

25 mg

100 Tablets

Carton labelCarton label

Package/Label Display Panel

Hydralazine HCl Tablets, USP

50 mg

100 Tablets

Carton labelCarton label

Package/Label Display Panel

Hydralazine HCl Tablets, USP

100 mg

100 Tablets

Carton label
(click image for full-size original)
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6440(NDC:23155-001)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
MAGNESIUM STEARATE
MINERAL OIL
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 7mm
Flavor Imprint Code HP;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6440-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6440-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086242 05/14/2015
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6441(NDC:23155-002)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
MAGNESIUM STEARATE
MINERAL OIL
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code HP;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6441-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6441-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086242 05/14/2015
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6442(NDC:23155-003)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
MAGNESIUM STEARATE
MINERAL OIL
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor Imprint Code HP;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6442-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6442-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086242 05/14/2015
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6443(NDC:23155-004)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
MAGNESIUM STEARATE
MINERAL OIL
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 11mm
Flavor Imprint Code HP;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6443-10 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0904-6443-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6443-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086242 05/14/2015
Labeler — Major Pharmaceuticals (191427277)

Revised: 06/2022 Major Pharmaceuticals

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