FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
68180-956
11-digit product format
681800956
Labeler code
68180
Product ID
68180-956_7b59c4a0-68c3-4423-adea-a4e2d5b1f96d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA210208
Marketing category
ANDA
Marketing start
2018-08-17
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-956-01Clobetasol Propionate1 in 1 CARTONCREAM18
68180-956-01Clobetasol Propionate15 g in 1 TUBECREAM158
68180-956-02Clobetasol Propionate30 g in 1 TUBECREAM308
68180-956-02Clobetasol Propionate1 in 1 CARTONCREAM18
68180-956-03Clobetasol Propionate45 g in 1 TUBECREAM458
68180-956-03Clobetasol Propionate1 in 1 CARTONCREAM18
68180-956-04Clobetasol Propionate1 in 1 CARTONCREAM18
68180-956-04Clobetasol Propionate60 g in 1 TUBECREAM608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-956-01GM - Gram68180-9562684a4c8-735d-4ca7-88b5-525bc606e09212018-09-05
68180-956-02GM - Gram68180-956d8e8c7d5-f4ca-48f6-a892-7c2e2bf26e8212018-09-05
68180-956-03GM - Gram68180-956225d6a3c-8efa-4c96-b063-c11b700d2bd812018-09-05
68180-956-04GM - Gram68180-9564dd4102c-3245-42a5-b41e-d4724eeb436e12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-956CLOBETASOL PROPIONATE CREAM [LUPIN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 8 package rows20250221_0a267001-0bff-471c-8852-808e6e3ea37c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN0a267001-0bff-471c-8852-808e6e3ea37c8
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD0a267001-0bff-471c-8852-808e6e3ea37c8
861495clobetasol propionate 0.05 % Topical CreamSY0a267001-0bff-471c-8852-808e6e3ea37c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-956-01681800956011 TUBE in 1 CARTON (68180-956-01) / 15 g in 1 TUBE1 tube2018-08-170000-00-00NoNoCurrent
68180-956-02681800956021 TUBE in 1 CARTON (68180-956-02) / 30 g in 1 TUBE1 tube2018-08-170000-00-00NoNoCurrent
68180-956-03681800956031 TUBE in 1 CARTON (68180-956-03) / 45 g in 1 TUBE1 tube2018-08-170000-00-00NoNoCurrent
68180-956-04681800956041 TUBE in 1 CARTON (68180-956-04) / 60 g in 1 TUBE1 tube2018-08-170000-00-00NoNoCurrent