Hydrocortisone Valerate

Product NDC
51672-1292
11-digit product format
516721292
Labeler code
51672
Product ID
51672-1292_39628349-b388-4030-e063-6394a90a6ce9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Valerate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075043
Marketing category
ANDA
Marketing start
1998-08-25
Substance
HYDROCORTISONE VALERATE
Active strength
2 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
Hydrocortisone Valerate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE VALERATE2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii68717P8FUZ
Rxcui1370750, 1370754

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1292-1Hydrocortisone Valerate1 in 1 CARTONOINTMENT17
51672-1292-1Hydrocortisone Valerate15 g in 1 TUBEOINTMENT157
51672-1292-3Hydrocortisone Valerate1 in 1 CARTONOINTMENT17
51672-1292-3Hydrocortisone Valerate60 g in 1 TUBEOINTMENT607
51672-1292-6Hydrocortisone Valerate1 in 1 CARTONOINTMENT17
51672-1292-6Hydrocortisone Valerate45 g in 1 TUBEOINTMENT457

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1292-1GM - Gram51672-1292407b7efb-fe7c-4d99-b7a1-5e52ec45574b12012-07-24
51672-1292-3GM - Gram51672-1292cd408db5-0798-493d-ab8e-b8d9e784a62612012-07-24
51672-1292-6GM - Gram51672-12926849bc3e-4fba-4583-8d73-42a0e921641812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrocortisone ValerateACTIVE INGREDIENT68717P8FUZHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
carbomer homopolymer type b (allyl pentaerythritol crosslinked)INACTIVE INGREDIENTHHT01ZNK31HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27EHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
steareth-100INACTIVE INGREDIENT4OH5W9UM87HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
HYDROCORTISONE VALERATEACTIVE INGREDIENT68717P8FUZHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
STEARETH-100INACTIVE INGREDIENT4OH5W9UM87HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1292HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20230129_a9011d6f-6808-48a7-ab6b-df8d40540570.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370754hydrocortisone valerate 0.2 % Topical CreamPSNa9011d6f-6808-48a7-ab6b-df8d405405707
1370750hydrocortisone valerate 0.2 % Topical OintmentPSNa9011d6f-6808-48a7-ab6b-df8d405405707
1370750hydrocortisone valerate 0.002 MG/MG Topical OintmentSCDa9011d6f-6808-48a7-ab6b-df8d405405707
1370754hydrocortisone valerate 2 MG/ML Topical CreamSCDa9011d6f-6808-48a7-ab6b-df8d405405707
1370754hydrocortisone valerate 0.2 % Topical CreamSYa9011d6f-6808-48a7-ab6b-df8d405405707
1370750hydrocortisone valerate 0.2 % Topical OintmentSYa9011d6f-6808-48a7-ab6b-df8d405405707
1370754hydrocortisone valerate 0.2 % Topical CreamPSN7b466e08-a51f-414c-bf87-eafed577ff2d1
1370750hydrocortisone valerate 0.2 % Topical OintmentPSN7b466e08-a51f-414c-bf87-eafed577ff2d1
1370750hydrocortisone valerate 0.002 MG/MG Topical OintmentSCD7b466e08-a51f-414c-bf87-eafed577ff2d1
1370754hydrocortisone valerate 2 MG/ML Topical CreamSCD7b466e08-a51f-414c-bf87-eafed577ff2d1
1370754hydrocortisone valerate 0.2 % Topical CreamSY7b466e08-a51f-414c-bf87-eafed577ff2d1
1370750hydrocortisone valerate 0.2 % Topical OintmentSY7b466e08-a51f-414c-bf87-eafed577ff2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1292-1516721292011 TUBE in 1 CARTON (51672-1292-1) / 15 g in 1 TUBE1 tube1998-08-250000-00-00NoNoCurrent
51672-1292-3516721292031 TUBE in 1 CARTON (51672-1292-3) / 60 g in 1 TUBE1 tube1998-08-250000-00-00NoNoCurrent
51672-1292-6516721292061 TUBE in 1 CARTON (51672-1292-6) / 45 g in 1 TUBE1 tube1998-08-250000-00-00NoNoCurrent