Doxycycline
Doxycycline Tablets, USP
Approved
Approval ID
3e526226-0ac6-4357-af89-23639e23ef58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2015
Manufacturers
FDA
Elorac, Inc.
DUNS: 832590009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42783-601
Application NumberANDA065285
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateOctober 8, 2015
FDA Product Classification
INGREDIENTS (12)
DOXYCYCLINEActive
Quantity: 100 mg in 1 1
Code: N12000U13O
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT