MedPath

Terazosin

TERAZOSIN CAPSULES, USP

Approved
Approval ID

9e7b27a6-cc09-407e-e053-2a95a90a17b3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 6, 2022

Manufacturers
FDA

AvPAK

DUNS: 832926666

Products 4

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

Terazosin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-767
Application NumberANDA075317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (10)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TERAZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: D32S14F082
Classification: ACTIM

Terazosin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-766
Application NumberANDA075317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (11)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TERAZOSIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: D32S14F082
Classification: ACTIM

Terazosin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-765
Application NumberANDA075317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (9)

GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TERAZOSIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: D32S14F082
Classification: ACTIM

Terazosin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-764
Application NumberANDA075317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (9)

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TERAZOSIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: D32S14F082
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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