FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
70700-106
11-digit product format
707000106
Labeler code
70700
Product ID
70700-106_c89c3b09-de28-9c1d-1f88-db05969f1868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Xiromed, LLC
Application
ANDA209701
Marketing category
ANDA
Marketing start
2018-05-01
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
Rxcui861448

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
70700-106-15Clobetasol Propionate15 g in 1 TUBEOINTMENT1517
70700-106-16Clobetasol Propionate30 g in 1 TUBEOINTMENT3017
70700-106-17Clobetasol Propionate60 g in 1 TUBEOINTMENT6017
70700-106-18Clobetasol Propionate45 g in 1 TUBEOINTMENT4517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-106-15GM - Gram70700-10696391f03-78f1-44ca-ab65-3e185403ae6812018-10-11
70700-106-16GM - Gram70700-10671b551d5-2dbe-4292-b149-f59d11dd06a212018-10-11
70700-106-17GM - Gram70700-1062939524f-2db0-4d19-9e64-c4498a2ebb8612018-10-11
70700-106-18GM - Gram70700-106b60d5430-6a45-48f7-ab60-ac9bf1c8b37d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-106CLOBETASOL PROPIONATE OINTMENT [XIROMED, LLC]17Current NDC, Legacy NDC, 4 package rows20230707_56e6d233-d9ee-f022-3be7-d100799a561e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN56e6d233-d9ee-f022-3be7-d100799a561e17
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD56e6d233-d9ee-f022-3be7-d100799a561e17
861448clobetasol propionate 0.05 % Topical OintmentSY56e6d233-d9ee-f022-3be7-d100799a561e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-106-157070001061515 g in 1 TUBE (70700-106-15) 15 g2018-05-010000-00-00NoNoCurrent
70700-106-167070001061630 g in 1 TUBE (70700-106-16) 30 g2018-05-010000-00-00NoNoCurrent
70700-106-177070001061760 g in 1 TUBE (70700-106-17) 60 g2018-05-010000-00-00NoNoCurrent
70700-106-187070001061845 g in 1 TUBE (70700-106-18) 45 g2018-05-010000-00-00NoNoCurrent