Minolira Extended Release
These highlights do not include all the information needed to use MINOLIRA™ safely and effectively. See full prescribing information for MINOLIRA. MINOLIRA™ (minocycline hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 1971
Approved
Approval ID
523856a4-530b-4a23-a80a-d72ab08e2c08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2022
Manufacturers
FDA
EPI Health, Inc
DUNS: 080638894
Products 2
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 Code71403-102
Application NumberNDA209269
Product Classification
M
Marketing Category
C73594
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2018
FDA Product Classification
INGREDIENTS (12)
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Minocycline HydrochlorideActive
Quantity: 135 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Hypromellose 2910 (5 Mpa.S)Inactive
Code: R75537T0T4
Classification: IACT
Ethylcellulose (10 Mpa.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
Hypromellose 2910 (15 Mpa.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Minocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71403-101
Application NumberNDA209269
Product Classification
M
Marketing Category
C73594
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2018
FDA Product Classification
INGREDIENTS (12)
Minocycline HydrochlorideActive
Quantity: 105 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Hypromellose 2910 (5 Mpa.S)Inactive
Code: R75537T0T4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Ethylcellulose (10 Mpa.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
Hypromellose 2910 (15 Mpa.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT