MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride capsule 
DirectRX

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MINOCYCLINE HYDROCHLORIDE

SPL Unclassified

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Description

Clinical Pharmacology

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

Animal Pharmacology and Toxicology

Patient Information

270

MINOCYCLINE HYDROCHLORIDE 
minocycline hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-270(NDC:13668-484)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE100 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SHELLAC (UNII: 46N107B71O)  
GELATIN (UNII: 2G86QN327L)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorgray (gray opaque cap, white opaque body) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code RX696
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-270-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06506203/14/2018
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-270)

Revised: 1/2020
Document Id: 9ca974dc-7422-abc6-e053-2995a90a767f
Set id: 25c33cb5-4244-3721-e054-00144ff8d46c
Version: 5
Effective Time: 20200121
 
DirectRX