Tetracycline Hydrochloride
TETRACYCLINE HYDROCHLORIDECAPSULES, USP
Approved
Approval ID
edf54a38-41a7-42ec-a05f-46ab20cb6fc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2013
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetracycline Hydrochloride
PRODUCT DETAILS
NDC Product Code53808-0877
Application NumberANDA061837
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2013
Generic NameTetracycline Hydrochloride
INGREDIENTS (23)
TETRACYCLINE HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: P6R62377KV
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
ETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: IDK7C2HS09
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT