Mycobutin

Product NDC
0013-5301
11-digit product format
000135301
Labeler code
0013
Product ID
0013-5301_47f0a676-c541-4d24-8710-bef6180556e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rifabutin
Dosage form
CAPSULE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050689
Marketing category
NDA
Marketing start
1992-12-23
Marketing end
0000-00-00
Substance
RIFABUTIN
Active strength
150 mg/1
Pharmacologic classes
Rifamycin Antimycobacterial [EPC],Rifamycins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
48b3639b-9f6e-fb03-0720-42e7d1e139acProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-5301-17EA - Each0013-5301501d253c-45f6-4e0a-a5d2-dc05f1134dd012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFABUTINACTIVE INGREDIENT1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
RIFABUTINACTIVE MOIETY1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
RIFABUTINACTIVE INGREDIENT1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
RIFABUTINACTIVE MOIETY1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0013-5301MYCOBUTIN (RIFABUTIN) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]24Legacy NDC20241225_3e1a6613-bdd3-4261-93b3-d7f5cc09064b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103899Mycobutin 150 MG Oral CapsulePSN2e050d5e-3175-2c6d-e054-00144ff88e881
198200rifabutin 150 MG Oral CapsulePSN2e050d5e-3175-2c6d-e054-00144ff88e881
103899rifabutin 150 MG Oral Capsule [Mycobutin]SBD2e050d5e-3175-2c6d-e054-00144ff88e881
198200rifabutin 150 MG Oral CapsuleSCD2e050d5e-3175-2c6d-e054-00144ff88e881
103899Mycobutin 150 MG Oral CapsuleSY2e050d5e-3175-2c6d-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0013-5301-1700013530117100 CAPSULE in 1 BOTTLE (0013-5301-17) 100 capsule1992-12-230000-00-00NoNoCurrent