FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
33342-506
11-digit product format
333420506
Labeler code
33342
Product ID
33342-506_92cf4231-e301-4353-98d9-85206ec6ba96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA215990
Marketing category
ANDA
Marketing start
2023-12-28
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
Brand name suffix
ANDA
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
33342-506-15Clobetasol PropionateANDA15 g in 1 TUBEOINTMENT151
33342-506-15Clobetasol PropionateANDA1 in 1 CARTONOINTMENT11
33342-506-30Clobetasol PropionateANDA1 in 1 CARTONOINTMENT11
33342-506-30Clobetasol PropionateANDA30 g in 1 TUBEOINTMENT301
33342-506-45Clobetasol PropionateANDA1 in 1 CARTONOINTMENT11
33342-506-45Clobetasol PropionateANDA45 g in 1 TUBEOINTMENT451
33342-506-60Clobetasol PropionateANDA60 g in 1 TUBEOINTMENT601
33342-506-60Clobetasol PropionateANDA1 in 1 CARTONOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-506-15GM - Gram33342-506c1767be1-0c4f-405f-9609-077414a9c4f012024-08-12
33342-506-30GM - Gram33342-50678eca22b-e0cd-44dc-a8cf-51851403007a12024-08-12
33342-506-45GM - Gram33342-506a1e73d34-8a0b-4311-8e64-6eb3f1ad922612024-08-12
33342-506-60GM - Gram33342-5069ee216a7-4fa6-485f-b20a-9017a24a7c5212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-506CLOBETASOL PROPIONATE ANDA (CLOBETASOL PROPIONATE) OINTMENT [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 8 package rows20240113_92cf4231-e301-4353-98d9-85206ec6ba96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN92cf4231-e301-4353-98d9-85206ec6ba961
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD92cf4231-e301-4353-98d9-85206ec6ba961
861448clobetasol propionate 0.05 % Topical OintmentSY92cf4231-e301-4353-98d9-85206ec6ba961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-506-15333420506151 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBE1 tube2023-12-28NoNoCurrent
33342-506-30333420506301 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBE1 tube2023-12-28NoNoCurrent
33342-506-45333420506451 TUBE in 1 CARTON (33342-506-45) / 45 g in 1 TUBE1 tube2023-12-28NoNoCurrent
33342-506-60333420506601 TUBE in 1 CARTON (33342-506-60) / 60 g in 1 TUBE1 tube2023-12-28NoNoCurrent