HYDROCORTISONE VALERATE

Product NDC
61919-010
11-digit product format
619190010
Labeler code
61919
Product ID
61919-010_9c9728d1-a5bd-556a-e053-2995a90a5994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE VALERATE
Dosage form
CREAM
Route
TOPICAL
Labeler
DIRECT RX
Application
ANDA075666
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE VALERATE
Active strength
2 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
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a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-010-152023-01-30C16284748780-1f386c649-f844-0266-e053-dadaa90a7c1aHYDROCORTISONE VALERATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-010-15HYDROCORTISONE VALERATE15 g in 1 TUBECREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-010-15GM - Gram61919-010e77286d2-4e2f-4116-b954-cd8db2f21ce512014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE VALERATEACTIVE INGREDIENT68717P8FUZHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE VALERATE CREAM [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROCORTISONE VALERATE CREAM [DIRECT RX]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE VALERATE CREAM [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-010HYDROCORTISONE VALERATE CREAM [DIRECT RX]3Legacy NDC, 1 package rows20200121_f165db21-1f03-4f33-8383-196f6adda6e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370754hydrocortisone valerate 0.2 % Topical CreamPSNf165db21-1f03-4f33-8383-196f6adda6e33
1370754hydrocortisone valerate 2 MG/ML Topical CreamSCDf165db21-1f03-4f33-8383-196f6adda6e33
1370754hydrocortisone valerate 0.2 % Topical CreamSYf165db21-1f03-4f33-8383-196f6adda6e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-010-156191900101515 g in 1 TUBE (61919-010-15) 15 g2015-01-010000-00-00NoNoCurrent