Clobetasol Propionate

Product NDC
68788-7963
11-digit product format
687887963
Labeler code
68788
Product ID
68788-7963_ff9104d2-9ae3-4205-995d-8df11c95e505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Ointment, 0.05%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211295
Marketing category
ANDA
Marketing start
2021-07-19
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
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
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
68788-7963-1Clobetasol Propionate15 g in 1 TUBEOINTMENT157
68788-7963-1Clobetasol Propionate1 in 1 CARTONOINTMENT17
68788-7963-3Clobetasol Propionate1 in 1 CARTONOINTMENT17
68788-7963-3Clobetasol Propionate30 g in 1 TUBEOINTMENT307
68788-7963-6Clobetasol Propionate60 g in 1 TUBEOINTMENT607
68788-7963-6Clobetasol Propionate1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7963-1GM - Gram68788-79639101650e-e188-4c34-9e78-2d167d998a4312021-08-05
68788-7963-3GM - Gram68788-7963c4c90402-bd84-4a6f-8e04-d038b96ef05c12021-08-05
68788-7963-6GM - Gram68788-79638e13f462-284d-4127-961b-7188ae87682112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7963CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT, 0.05%) OINTMENT [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 6 package rows20250308_087c5aee-d7fd-42ce-b213-14c810292808.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN087c5aee-d7fd-42ce-b213-14c8102928087
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD087c5aee-d7fd-42ce-b213-14c8102928087
861448clobetasol propionate 0.05 % Topical OintmentSY087c5aee-d7fd-42ce-b213-14c8102928087

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7963-1687887963011 TUBE in 1 CARTON (68788-7963-1) / 15 g in 1 TUBE1 tube2021-07-190000-00-00NoNoCurrent
68788-7963-3687887963031 TUBE in 1 CARTON (68788-7963-3) / 30 g in 1 TUBE1 tube2021-07-190000-00-00NoNoCurrent
68788-7963-6687887963061 TUBE in 1 CARTON (68788-7963-6) / 60 g in 1 TUBE1 tube2021-07-190000-00-00NoNoCurrent