FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
70700-109
11-digit product format
707000109
Labeler code
70700
Product ID
70700-109_3c32f122-0b2c-5c00-e063-6294a90a0a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Xiromed, LLC
Application
ANDA210034
Marketing category
ANDA
Marketing start
2018-06-19
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861495

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
70700-109-15Clobetasol Propionate15 g in 1 TUBECREAM159
70700-109-15Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-16Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-16Clobetasol Propionate30 g in 1 TUBECREAM309
70700-109-17Clobetasol Propionate60 g in 1 TUBECREAM609
70700-109-17Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-18Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-18Clobetasol Propionate45 g in 1 TUBECREAM459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-109-15GM - Gram70700-10971f5d1fe-d2f8-4b31-a1d0-92827d9be98112018-11-06
70700-109-16GM - Gram70700-109587dd34a-fe17-44b8-a27c-83500ccef67512018-11-06
70700-109-17GM - Gram70700-109c8da7f30-34d8-4ff4-986a-39d948e9701412018-11-06
70700-109-18GM - Gram70700-10915dbe110-7b7c-46fe-963d-c4b341bf987512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-109CLOBETASOL PROPIONATE CREAM [XIROMED, LLC]8Current NDC, Legacy NDC, 8 package rows20230707_2556987f-4b0f-8a83-5bf4-095d67a450b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN9856b731-0676-405d-817c-de385cbd08a3104
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD9856b731-0676-405d-817c-de385cbd08a3104
861495clobetasol propionate 0.05 % Topical CreamSY9856b731-0676-405d-817c-de385cbd08a3104
861495clobetasol propionate 0.05 % Topical CreamPSN21a63bc2-a42a-412c-8dd5-17e279f99f27103
861495clobetasol propionate 0.05 % Topical CreamPSN6d14d269-bae6-493a-81ed-83f6a3aa0f4f103
861495clobetasol propionate 0.05 % Topical CreamPSN643682ee-39c8-4a0d-b131-f30077e6e20a103
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD21a63bc2-a42a-412c-8dd5-17e279f99f27103
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD6d14d269-bae6-493a-81ed-83f6a3aa0f4f103
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD643682ee-39c8-4a0d-b131-f30077e6e20a103
861495clobetasol propionate 0.05 % Topical CreamSY21a63bc2-a42a-412c-8dd5-17e279f99f27103
861495clobetasol propionate 0.05 % Topical CreamSY6d14d269-bae6-493a-81ed-83f6a3aa0f4f103
861495clobetasol propionate 0.05 % Topical CreamSY643682ee-39c8-4a0d-b131-f30077e6e20a103
861495clobetasol propionate 0.05 % Topical CreamPSN4990e4c7-78b3-4bc8-85d0-6d58f08121ff101
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD4990e4c7-78b3-4bc8-85d0-6d58f08121ff101
861495clobetasol propionate 0.05 % Topical CreamSY4990e4c7-78b3-4bc8-85d0-6d58f08121ff101
861495clobetasol propionate 0.05 % Topical CreamPSN2556987f-4b0f-8a83-5bf4-095d67a450b49
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD2556987f-4b0f-8a83-5bf4-095d67a450b49
861495clobetasol propionate 0.05 % Topical CreamSY2556987f-4b0f-8a83-5bf4-095d67a450b49
861495clobetasol propionate 0.05 % Topical CreamPSN52bf5318-2487-4c7b-aa8d-e98f22cc61048
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD52bf5318-2487-4c7b-aa8d-e98f22cc61048
861495clobetasol propionate 0.05 % Topical CreamSY52bf5318-2487-4c7b-aa8d-e98f22cc61048

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-109-15707000109151 TUBE in 1 CARTON (70700-109-15) / 15 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent
70700-109-16707000109161 TUBE in 1 CARTON (70700-109-16) / 30 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent
70700-109-17707000109171 TUBE in 1 CARTON (70700-109-17) / 60 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent
70700-109-18707000109181 TUBE in 1 CARTON (70700-109-18) / 45 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent