Mycobutin (Page 6 of 6)

HOW SUPPLIED

MYCOBUTIN (rifabutin) Capsules, USP are supplied as hard gelatin capsules having an opaque red-brown cap and body, imprinted with MYCOBUTIN/PHARMACIA & UPJOHN in white ink, each containing 150 mg of rifabutin, USP.

MYCOBUTIN is available as follows:

NDC 0013-5301-17 Bottles of 100 capsules

Keep tightly closed and dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Logo

LAB-0217-11.0
Revised 9/2021

PRINCIPAL DISPLAY PANEL — 150 mg Capsule Bottle Label

Pfizer
NDC 0013-5301-17

Mycobutin®
(rifabutin) capsules, USP

150 mg

100 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 150 mg Capsule Bottle Label
(click image for full-size original)
MYCOBUTIN rifabutin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0013-5301
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIFABUTIN (RIFABUTIN) RIFABUTIN 150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
FERRIC OXIDE RED
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color RED (red-brown) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code MYCOBUTIN;PHARMACIA;UPJOHN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0013-5301-17 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050689 12/23/1992
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Italia S.r.l. 458521908 ANALYSIS (0013-5301), MANUFACTURE (0013-5301), PACK (0013-5301), LABEL (0013-5301)

Revised: 11/2021 Pfizer Laboratories Div Pfizer Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.