DYNACIN
Approved
Approval ID
f174edbd-3ac0-4e27-a116-3b74804721bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2014
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-097
Application NumberANDA065131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2014
FDA Product Classification
INGREDIENTS (11)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-098
Application NumberANDA065131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2014
FDA Product Classification
INGREDIENTS (11)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-096
Application NumberANDA065131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2014
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT