Minocycline Hydrochloride
MinocyclineHydrochlorideCapsules USP Revised: July 2014 Rx only
Approved
Approval ID
36120c7e-69b3-40c1-b37d-a4d3a3ccee7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2016
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
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 Code43353-105
Application NumberANDA063065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2014
FDA Product Classification
INGREDIENTS (10)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT