Clobetasol Propionate

Product NDC
16714-782
11-digit product format
167140782
Labeler code
16714
Product ID
16714-782_683b22fa-b609-40de-8547-73b9d1120c22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Northstar Rx LLC
Application
ANDA208933
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
16714-782-01Clobetasol Propionate15 g in 1 TUBEOINTMENT153
16714-782-01Clobetasol Propionate1 in 1 CARTONOINTMENT13
16714-782-02Clobetasol Propionate30 g in 1 TUBEOINTMENT303
16714-782-02Clobetasol Propionate1 in 1 CARTONOINTMENT13
16714-782-03Clobetasol Propionate45 g in 1 TUBEOINTMENT453
16714-782-03Clobetasol Propionate1 in 1 CARTONOINTMENT13
16714-782-04Clobetasol Propionate1 in 1 CARTONOINTMENT13
16714-782-04Clobetasol Propionate60 g in 1 TUBEOINTMENT603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-782CLOBETASOL PROPIONATE OINTMENT [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 8 package rows20240626_0d0e8e82-2b57-4cc0-a46b-bd08fb581deb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN846f1ae1-0a7f-4609-b1a0-c749ffc79ce87
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD846f1ae1-0a7f-4609-b1a0-c749ffc79ce87
861448clobetasol propionate 0.05 % Topical OintmentSY846f1ae1-0a7f-4609-b1a0-c749ffc79ce87
861448clobetasol propionate 0.05 % Topical OintmentPSN0d0e8e82-2b57-4cc0-a46b-bd08fb581deb3
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD0d0e8e82-2b57-4cc0-a46b-bd08fb581deb3
861448clobetasol propionate 0.05 % Topical OintmentSY0d0e8e82-2b57-4cc0-a46b-bd08fb581deb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-782-01167140782011 TUBE in 1 CARTON (16714-782-01) > 15 g in 1 TUBE1 tube2018-05-010000-00-00NoNoCurrent
16714-782-02167140782021 TUBE in 1 CARTON (16714-782-02) > 30 g in 1 TUBE1 tube2018-05-010000-00-00NoNoCurrent
16714-782-03167140782031 TUBE in 1 CARTON (16714-782-03) > 45 g in 1 TUBE1 tube2018-05-010000-00-00NoNoCurrent
16714-782-04167140782041 TUBE in 1 CARTON (16714-782-04) > 60 g in 1 TUBE1 tube2018-05-010000-00-00NoNoCurrent