Minocycline Hydrochloride
These highlights do not include all the information needed to use MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. MINOCYCLINE HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1971
Approved
Approval ID
e7b88a48-12b3-461d-b356-0d7ae4e8fd44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 6, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 8
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 Code65862-558
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (11)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 135 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-884
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-885
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (12)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 105 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-555
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (12)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 65 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-554
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 45 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-557
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (11)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 115 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-556
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (11)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-883
Application NumberANDA202261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2022
FDA Product Classification
INGREDIENTS (11)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 55 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT