Hydrocortisone Butyrate

Product NDC
21695-971
11-digit product format
216950971
Labeler code
21695
Product ID
21695-971_0db4485b-2924-4113-af76-117ad48367b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Butyrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
NDA018514
Marketing category
NDA
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE BUTYRATE
Active strength
1 mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-971-152019-09-24C16284748780-1934fe258-4b7e-48b1-e053-8cdaa90a720aHydrocortisone Butyrate Cream, USP, 0.1% For Dermatological Use Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-971-15Hydrocortisone Butyrate1 in 1 CARTONCREAM11
21695-971-15Hydrocortisone Butyrate15 g in 1 TUBECREAM151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-971-15GM - Gram21695-971facdc079-8c11-4e90-9c2d-9fd0eb9a789212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-971HYDROCORTISONE BUTYRATE CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110914_0db4485b-2924-4113-af76-117ad48367b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370770hydrocortisone butyrate 0.1 % Topical CreamPSN0db4485b-2924-4113-af76-117ad48367b61
1370770hydrocortisone butyrate 1 MG/ML Topical CreamSCD0db4485b-2924-4113-af76-117ad48367b61
1370770hydrocortisone butyrate 0.1 % Topical CreamSY0db4485b-2924-4113-af76-117ad48367b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-971-15216950971151 in 1 CARTONHistorical