Tetracycline Hydrochloride
TETRACYCLINE HYDROCHLORIDE CAPSULES USP
Approved
Approval ID
b45cee2a-8d11-4fda-b8f8-e1f71abf87c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetracycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0025
Application NumberANDA060704
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tetracycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2011
FDA Product Classification
INGREDIENTS (8)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TETRACYCLINE HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: P6R62377KV
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Tetracycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0024
Application NumberANDA060704
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tetracycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2011
FDA Product Classification
INGREDIENTS (7)
TETRACYCLINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: P6R62377KV
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT