FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
42291-076
11-digit product format
422910076
Labeler code
42291
Product ID
42291-076_485b57d4-89e6-6842-e063-6294a90a6362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
AvKARE
Application
ANDA211256
Marketing category
ANDA
Marketing start
2020-06-18
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-076-15Clobetasol Propionate15 g in 1 TUBECREAM154
42291-076-15Clobetasol Propionate1 in 1 CARTONCREAM14
42291-076-30Clobetasol Propionate30 g in 1 TUBECREAM304
42291-076-30Clobetasol Propionate1 in 1 CARTONCREAM14
42291-076-45Clobetasol Propionate45 g in 1 TUBECREAM454
42291-076-45Clobetasol Propionate1 in 1 CARTONCREAM14
42291-076-60Clobetasol Propionate1 in 1 CARTONCREAM14
42291-076-60Clobetasol Propionate60 g in 1 TUBECREAM604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-076-15GM - Gram42291-0768f92dfa1-5b27-4a82-bb3a-1c2197db180412020-07-13
42291-076-30GM - Gram42291-07682a89555-ab7f-46f7-84d4-5ea7dad0472812020-07-13
42291-076-45GM - Gram42291-076d55aa326-a013-4e22-a762-d9ec3a4d4ff312020-07-13
42291-076-60GM - Gram42291-076d047e5b3-6386-4e81-bd1e-25d8e8d6fde312020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-076CLOBETASOL PROPIONATE CREAM [AVKARE]3Current NDC, Legacy NDC, 8 package rows20240110_a86241e0-3187-e468-e053-2995a90a1ae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSNa86241e0-3187-e468-e053-2995a90a1ae54
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDa86241e0-3187-e468-e053-2995a90a1ae54
861495clobetasol propionate 0.05 % Topical CreamSYa86241e0-3187-e468-e053-2995a90a1ae54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-076-15422910076151 TUBE in 1 CARTON (42291-076-15) / 15 g in 1 TUBE1 tube2020-06-180000-00-00NoNoCurrent
42291-076-30422910076301 TUBE in 1 CARTON (42291-076-30) / 30 g in 1 TUBE1 tube2020-06-180000-00-00NoNoCurrent
42291-076-45422910076451 TUBE in 1 CARTON (42291-076-45) / 45 g in 1 TUBE1 tube2020-06-180000-00-00NoNoCurrent
42291-076-60422910076601 TUBE in 1 CARTON (42291-076-60) / 60 g in 1 TUBE1 tube2020-06-180000-00-00NoNoCurrent