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
NDC Product Code49884-097
Application NumberANDA065131
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 18, 2014
Generic NameMinocycline Hydrochloride
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
NDC Product Code49884-098
Application NumberANDA065131
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 18, 2014
Generic NameMinocycline Hydrochloride
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
NDC Product Code49884-096
Application NumberANDA065131
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 18, 2014
Generic NameMinocycline Hydrochloride
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