Clobetasol Propionate

Product NDC
51672-1258
11-digit product format
516721258
Labeler code
51672
Product ID
51672-1258_4db5c318-4c64-4e2c-e063-6294a90aa7f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA074249
Marketing category
ANDA
Marketing start
1996-07-08
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861434, 861448, 861495

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1258-1Clobetasol Propionate15 g in 1 TUBECREAM1511
51672-1258-1Clobetasol Propionate1 in 1 CARTONCREAM111
51672-1258-2Clobetasol Propionate30 g in 1 TUBECREAM3011
51672-1258-2Clobetasol Propionate1 in 1 CARTONCREAM111
51672-1258-3Clobetasol Propionate1 in 1 CARTONCREAM111
51672-1258-3Clobetasol Propionate60 g in 1 TUBECREAM6011
51672-1258-6Clobetasol Propionate45 g in 1 TUBECREAM4511
51672-1258-6Clobetasol Propionate1 in 1 CARTONCREAM111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1258-1GM - Gram51672-12583635b111-0b50-4d68-a867-e4b4d0feae8f12012-07-24
51672-1258-2GM - Gram51672-1258d0e0bdb3-ae0f-43f0-a898-c3d64cc3fba112012-07-24
51672-1258-3GM - Gram51672-12583ac5ceda-39e1-4128-8467-9b5da4b9f31412012-07-24
51672-1258-6GM - Gram51672-1258616f7652-9f3c-42bd-8af7-eb1a78d39dbf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clobetasol PropionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
ClobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
chlorocresolINACTIVE INGREDIENT36W53O7109CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
petrolatumINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sorbitan sesquioleateINACTIVE INGREDIENT0W8RRI5W5ACLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
white waxINACTIVE INGREDIENT7G1J5DA97FCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1258CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]8Current NDC, Legacy NDC, 8 package rows20230519_4a761afb-a48a-4a5a-8700-ad93601a260f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN4a761afb-a48a-4a5a-8700-ad93601a260f11
861434clobetasol propionate 0.05 % Topical GelPSN4a761afb-a48a-4a5a-8700-ad93601a260f11
861448clobetasol propionate 0.05 % Topical OintmentPSN4a761afb-a48a-4a5a-8700-ad93601a260f11
861434clobetasol propionate 0.0005 MG/MG Topical GelSCD4a761afb-a48a-4a5a-8700-ad93601a260f11
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD4a761afb-a48a-4a5a-8700-ad93601a260f11
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD4a761afb-a48a-4a5a-8700-ad93601a260f11
861495clobetasol propionate 0.05 % Topical CreamSY4a761afb-a48a-4a5a-8700-ad93601a260f11
861434clobetasol propionate 0.05 % Topical GelSY4a761afb-a48a-4a5a-8700-ad93601a260f11
861448clobetasol propionate 0.05 % Topical OintmentSY4a761afb-a48a-4a5a-8700-ad93601a260f11
861495clobetasol propionate 0.05 % Topical CreamPSNecef6314-97c0-4f2e-bbcb-53a62ac7fb727
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDecef6314-97c0-4f2e-bbcb-53a62ac7fb727
861495clobetasol propionate 0.05 % Topical CreamSYecef6314-97c0-4f2e-bbcb-53a62ac7fb727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1258-1516721258011 TUBE in 1 CARTON (51672-1258-1) / 15 g in 1 TUBE1 tube1996-07-080000-00-00NoNoCurrent
51672-1258-2516721258021 TUBE in 1 CARTON (51672-1258-2) / 30 g in 1 TUBE1 tube1996-07-080000-00-00NoNoCurrent
51672-1258-3516721258031 TUBE in 1 CARTON (51672-1258-3) / 60 g in 1 TUBE1 tube1996-07-080000-00-00NoNoCurrent
51672-1258-6516721258061 TUBE in 1 CARTON (51672-1258-6) / 45 g in 1 TUBE1 tube1996-07-080000-00-00NoNoCurrent