MINOCYCLINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride capsule
DirectRX

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE) MINOCYCLINE 100 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE STARCH, CORN FERROSOFERRIC OXIDE SHELLAC GELATIN POTASSIUM HYDROXIDE TITANIUM DIOXIDE PROPYLENE GLYCOL

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 Multilevel Packaging 1 NDC:61919-270-20 20 CAPSULE in 1 BOTTLE None 2 NDC:61919-270-30 30 CAPSULE in 1 BOTTLE None

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	Operations
DirectRX		079254320	repack (61919-270)

Revised: 06/2022 DirectRX