Clobetasol Propionate

Product NDC
52565-039
11-digit product format
525650039
Labeler code
52565
Product ID
52565-039_e595ff4a-5878-4096-b05b-c50d5844ebc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208589
Marketing category
ANDA
Marketing start
2019-01-23
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-039-15Clobetasol Propionate15 g in 1 TUBEOINTMENT154
52565-039-15Clobetasol Propionate1 in 1 CARTONOINTMENT14
52565-039-30Clobetasol Propionate1 in 1 CARTONOINTMENT14
52565-039-30Clobetasol Propionate30 g in 1 TUBEOINTMENT304
52565-039-45Clobetasol Propionate1 in 1 CARTONOINTMENT14
52565-039-45Clobetasol Propionate45 g in 1 TUBEOINTMENT454
52565-039-60Clobetasol Propionate60 g in 1 TUBEOINTMENT604
52565-039-60Clobetasol Propionate1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-039-15GM - Gram52565-039ecfc5de9-136f-4fb6-ae2f-3a944df8751f12019-03-12
52565-039-30GM - Gram52565-0397de1cbd5-9bde-4a8a-8b01-7abffe66a08312019-03-12
52565-039-45GM - Gram52565-03932c9921d-1943-47bb-9b00-6c007737e75b12019-03-12
52565-039-60GM - Gram52565-039c844fc75-11d0-4e59-bfdc-51ccc7ab85d912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-039CLOBETASOL PROPIONATE OINTMENT [TELIGENT PHARMA, INC.]4Legacy NDC, 8 package rows20210911_1145ee2c-e7b4-1bd2-77fb-74245bbdef94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN1145ee2c-e7b4-1bd2-77fb-74245bbdef944
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD1145ee2c-e7b4-1bd2-77fb-74245bbdef944
861448clobetasol propionate 0.05 % Topical OintmentSY1145ee2c-e7b4-1bd2-77fb-74245bbdef944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-039-15525650039151 TUBE in 1 CARTON (52565-039-15) > 15 g in 1 TUBE1 tube2019-01-230000-00-00NoNoCurrent
52565-039-30525650039301 TUBE in 1 CARTON (52565-039-30) > 30 g in 1 TUBE1 tube2019-01-230000-00-00NoNoCurrent
52565-039-45525650039451 TUBE in 1 CARTON (52565-039-45) > 45 g in 1 TUBE1 tube2019-01-230000-00-00NoNoCurrent
52565-039-60525650039601 TUBE in 1 CARTON (52565-039-60) > 60 g in 1 TUBE1 tube2019-01-230000-00-00NoNoCurrent