MedPath

Hydrochlorothiazide

HYDROCHLOROTHIAZIDE TABLETS USPRx Only

Approved
Approval ID

e6edac46-8e5d-4180-a35e-510ecd534367

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 6, 2010

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-272
Application NumberANDA084878
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2009
FDA Product Classification

INGREDIENTS (8)

FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

Hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-271
Application NumberANDA084878
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2009
FDA Product Classification

INGREDIENTS (8)

HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

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