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Demeclocycline Hydrochloride

DEMECLOCYCLINE HYDROCHLORIDE Tablets, USP (Film Coated)

Approved
Approval ID

b60e9a8b-c315-40a8-baa1-d0739489b293

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 1, 2010

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

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

Demeclocycline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-0155
Application NumberANDA065425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Demeclocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2010
FDA Product Classification

INGREDIENTS (14)

POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
DEMECLOCYCLINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 29O079NTYT
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT

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Demeclocycline Hydrochloride - FDA Drug Approval Details