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Doxycycline Hyclate

DOXYCYCLINE HYCLATE TABLETS USPRx only

Approved
Approval ID

e563fe71-0316-4caf-9b50-59e2c5e2596e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 20, 2012

Manufacturers
FDA

HHS/Program Support Center/Supply Service Center

DUNS: 194032918

Products 1

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

Doxycycline Hyclate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11819-305
Application NumberANDA062505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2012
FDA Product Classification

INGREDIENTS (13)

METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Doxycycline HyclateActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Doxycycline Hyclate - FDA Drug Approval Details