Minocycline Hydrochloride
MINOCYCLINE HYDROCHLORIDE CAPSULES, USPRx only
Approved
Approval ID
55df55fb-18ec-4e00-9ed0-10bba0da513b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Torrent Pharmaceuticals Limited
DUNS: 650175722
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 Code13668-483
Application NumberANDA065062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification
INGREDIENTS (9)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-484
Application NumberANDA065062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification
INGREDIENTS (9)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-482
Application NumberANDA065062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification
INGREDIENTS (9)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 0020414E5U
Classification: ACTIM