FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
21922-017
11-digit product format
219220017
Labeler code
21922
Product ID
21922-017_450ced89-15f5-4316-860a-59915e779025
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Ointment USP, 0.05%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA211295
Marketing category
ANDA
Marketing start
2019-11-18
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
21922-017-04Clobetasol Propionate1 in 1 CARTONOINTMENT16
21922-017-04Clobetasol Propionate15 g in 1 TUBEOINTMENT156
21922-017-05Clobetasol Propionate1 in 1 CARTONOINTMENT16
21922-017-05Clobetasol Propionate30 g in 1 TUBEOINTMENT306
21922-017-06Clobetasol Propionate1 in 1 CARTONOINTMENT16
21922-017-06Clobetasol Propionate45 g in 1 TUBEOINTMENT456
21922-017-07Clobetasol Propionate1 in 1 CARTONOINTMENT16
21922-017-07Clobetasol Propionate60 g in 1 TUBEOINTMENT606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-017-04GM - Gram21922-017f3d97b95-65fe-4142-af98-7d2f366fe40912020-02-13
21922-017-05GM - Gram21922-0177754f41d-9c99-40fd-806d-c4560f5caabb12020-02-13
21922-017-06GM - Gram21922-0178ca1d6af-0bb5-476d-b320-e4a609d8801712020-02-13
21922-017-07GM - Gram21922-01747867d64-036e-45d6-b275-1215c7fee20f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-017CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]5Current NDC, Legacy NDC, 8 package rows20241212_1f076779-3f76-47d5-99f0-9b0b2d3f5fac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSNd6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2108
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCDd6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2108
861448clobetasol propionate 0.05 % Topical OintmentSYd6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2108
861448clobetasol propionate 0.05 % Topical OintmentPSN032f1f4e-1f1c-409a-8fac-6449ee543caa107
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD032f1f4e-1f1c-409a-8fac-6449ee543caa107
861448clobetasol propionate 0.05 % Topical OintmentSY032f1f4e-1f1c-409a-8fac-6449ee543caa107
861448clobetasol propionate 0.05 % Topical OintmentPSN60f65ee3-b972-4e58-97fe-0c0ab14b9b48106
861448clobetasol propionate 0.05 % Topical OintmentPSN3dcc49e7-a4f8-44cf-9405-2786bdc910cb106
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD60f65ee3-b972-4e58-97fe-0c0ab14b9b48106
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD3dcc49e7-a4f8-44cf-9405-2786bdc910cb106
861448clobetasol propionate 0.05 % Topical OintmentSY60f65ee3-b972-4e58-97fe-0c0ab14b9b48106
861448clobetasol propionate 0.05 % Topical OintmentSY3dcc49e7-a4f8-44cf-9405-2786bdc910cb106
861448clobetasol propionate 0.05 % Topical OintmentPSNfa0e3c04-4b45-4aca-8b59-7df2ec3963e7100
861448clobetasol propionate 0.05 % Topical OintmentPSN7c71c9a8-9c76-4de4-982f-42eb54b7689c100
861448clobetasol propionate 0.05 % Topical OintmentPSN4d9b83e8-593e-4add-ac1d-c8eea25761bc100
861448clobetasol propionate 0.05 % Topical OintmentPSN09717dc5-eef3-4f50-a346-f91d7e86fec9100
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCDfa0e3c04-4b45-4aca-8b59-7df2ec3963e7100
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD4d9b83e8-593e-4add-ac1d-c8eea25761bc100
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD09717dc5-eef3-4f50-a346-f91d7e86fec9100
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD7c71c9a8-9c76-4de4-982f-42eb54b7689c100
861448clobetasol propionate 0.05 % Topical OintmentSYfa0e3c04-4b45-4aca-8b59-7df2ec3963e7100
861448clobetasol propionate 0.05 % Topical OintmentSY4d9b83e8-593e-4add-ac1d-c8eea25761bc100
861448clobetasol propionate 0.05 % Topical OintmentSY09717dc5-eef3-4f50-a346-f91d7e86fec9100
861448clobetasol propionate 0.05 % Topical OintmentSY7c71c9a8-9c76-4de4-982f-42eb54b7689c100
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
861448clobetasol propionate 0.05 % Topical OintmentPSN1f076779-3f76-47d5-99f0-9b0b2d3f5fac6
861448clobetasol propionate 0.05 % Topical OintmentPSN485e931d-16a7-4e92-996e-d3b32d9f41e76
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD1f076779-3f76-47d5-99f0-9b0b2d3f5fac6
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD485e931d-16a7-4e92-996e-d3b32d9f41e76
861448clobetasol propionate 0.05 % Topical OintmentSY1f076779-3f76-47d5-99f0-9b0b2d3f5fac6
861448clobetasol propionate 0.05 % Topical OintmentSY485e931d-16a7-4e92-996e-d3b32d9f41e76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-017-04219220017041 TUBE in 1 CARTON (21922-017-04) / 15 g in 1 TUBE1 tube2019-11-180000-00-00NoNoCurrent
21922-017-05219220017051 TUBE in 1 CARTON (21922-017-05) / 30 g in 1 TUBE1 tube2019-11-180000-00-00NoNoCurrent
21922-017-06219220017061 TUBE in 1 CARTON (21922-017-06) / 45 g in 1 TUBE1 tube2019-11-180000-00-00NoNoCurrent
21922-017-07219220017071 TUBE in 1 CARTON (21922-017-07) / 60 g in 1 TUBE1 tube2019-11-180000-00-00NoNoCurrent