MINOCYCLINE HYDROCHLORIDE capsule

MINOCYCLINE HYDROCHLORIDE by

Drug Labeling and Warnings

MINOCYCLINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by DirectRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INDICATIONS & USAGE

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

Animal Pharmacology and Toxicology

Patient Information

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINOCYCLINE HYDROCHLORIDE 
minocycline hydrochloride capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-270(NDC:13668-484)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)	MINOCYCLINE	100 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	gray (gray opaque cap, white opaque body)	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	RX696
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-270-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065062	03/14/2018

Labeler - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	repack(61919-270)