Solodyn
These highlights do not include all the information needed to use SOLODYN safely and effectively. See full prescribing information for SOLODYN. SOLODYN (minocycline HCl) Extended Release Tablets for oral use Initial U.S. Approval: 1971
Approved
Approval ID
1b9dfa57-f295-4038-8aec-8efc54817d07
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2017
Manufacturers
FDA
Bausch Health US LLC
DUNS: 831922468
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 Code99207-467
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (8)
minocycline hydrochlorideActive
Quantity: 105 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
D&C Red No. 27Inactive
Code: 2LRS185U6K
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
minocycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code99207-460
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (6)
minocycline hydrochlorideActive
Quantity: 45 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
hypromellose 2910 (50 mpa.s)Inactive
Code: 1IVH67816N
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
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 Code99207-463
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (9)
minocycline hydrochlorideActive
Quantity: 65 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
minocycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code99207-461
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (7)
minocycline hydrochlorideActive
Quantity: 90 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
minocycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code99207-464
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (8)
minocycline hydrochlorideActive
Quantity: 115 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
minocycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code99207-462
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (7)
triacetinInactive
Code: XHX3C3X673
Classification: IACT
minocycline hydrochlorideActive
Quantity: 135 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
minocycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code99207-465
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (7)
minocycline hydrochlorideActive
Quantity: 55 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
minocycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code99207-466
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (9)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
minocycline hydrochlorideActive
Quantity: 80 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT