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

61919-270-30

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61919-270-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2018
2	NDC:61919-270-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2018

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

Labeler - DirectRX (079254320)

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