FDA.reportPublic FDA data

Hydrocortisone

Product NDC
45802-014
11-digit product format
458020014
Labeler code
45802
Product ID
45802-014_4b485448-cd59-492b-89cf-8b0582751e44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA085027
Marketing category
ANDA
Marketing start
2006-06-13
Substance
HYDROCORTISONE
Active strength
25 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
Hydrocortisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui103401, 310891

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
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
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
45802-014-02Hydrocortisone20 g in 1 TUBEOINTMENT2013
45802-014-02Hydrocortisone1 in 1 CARTONOINTMENT113
45802-014-05Hydrocortisone454 g in 1 JAROINTMENT45413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-014-02GM - Gram45802-014be6616b7-eb76-4f79-9a0b-7762b99c5a1312012-07-24
45802-014-05GM - Gram45802-0140f38b8ac-3829-44dc-a8e9-5d5717dd62ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-014HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]12Current NDC, Legacy NDC, 3 package rows20240430_7ba59aa6-b828-4048-bf86-90c90d9894a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103401hydrocortisone 2.5 % Topical OintmentPSN2dda4f32-e0f6-4e8d-8d75-10da5b762790108
103401hydrocortisone 0.025 MG/MG Topical OintmentSCD2dda4f32-e0f6-4e8d-8d75-10da5b762790108
103401hydrocortisone 2.5 % Topical OintmentSY2dda4f32-e0f6-4e8d-8d75-10da5b762790108
103401hydrocortisone 2.5 % Topical OintmentPSN9f64ed9d-64c8-48e9-ac54-1aa9b26a6060106
103401hydrocortisone 0.025 MG/MG Topical OintmentSCD9f64ed9d-64c8-48e9-ac54-1aa9b26a6060106
103401hydrocortisone 2.5 % Topical OintmentSY9f64ed9d-64c8-48e9-ac54-1aa9b26a6060106
103401hydrocortisone 2.5 % Topical OintmentPSN0ae1ba79-3992-4910-b03f-6f9b0f26e300104
103401hydrocortisone 2.5 % Topical OintmentPSNc3916e9f-f783-45a2-b38b-959b12c26252104
103401hydrocortisone 0.025 MG/MG Topical OintmentSCDc3916e9f-f783-45a2-b38b-959b12c26252104
103401hydrocortisone 0.025 MG/MG Topical OintmentSCD0ae1ba79-3992-4910-b03f-6f9b0f26e300104
103401hydrocortisone 2.5 % Topical OintmentSY0ae1ba79-3992-4910-b03f-6f9b0f26e300104
103401hydrocortisone 2.5 % Topical OintmentSYc3916e9f-f783-45a2-b38b-959b12c26252104
103401hydrocortisone 2.5 % Topical OintmentPSNa3fbdae4-d1dc-42de-939f-f9a7aab60e4915
103401hydrocortisone 0.025 MG/MG Topical OintmentSCDa3fbdae4-d1dc-42de-939f-f9a7aab60e4915
103401hydrocortisone 2.5 % Topical OintmentSYa3fbdae4-d1dc-42de-939f-f9a7aab60e4915
310891hydrocortisone 2.5 % Topical CreamPSN7ba59aa6-b828-4048-bf86-90c90d9894a013
103401hydrocortisone 2.5 % Topical OintmentPSN7ba59aa6-b828-4048-bf86-90c90d9894a013
103401hydrocortisone 0.025 MG/MG Topical OintmentSCD7ba59aa6-b828-4048-bf86-90c90d9894a013
310891hydrocortisone 25 MG/ML Topical CreamSCD7ba59aa6-b828-4048-bf86-90c90d9894a013
310891hydrocortisone 2.5 % Topical CreamSY7ba59aa6-b828-4048-bf86-90c90d9894a013
103401hydrocortisone 2.5 % Topical OintmentSY7ba59aa6-b828-4048-bf86-90c90d9894a013
103401hydrocortisone 2.5 % Topical OintmentPSNf9b498e2-be9d-209f-e053-6394a90a9cc01
103401hydrocortisone 2.5 % Topical OintmentPSN848574fe-a23e-4e15-8c29-d624f50b71de1
103401hydrocortisone 0.025 MG/MG Topical OintmentSCD848574fe-a23e-4e15-8c29-d624f50b71de1
103401hydrocortisone 0.025 MG/MG Topical OintmentSCDf9b498e2-be9d-209f-e053-6394a90a9cc01
103401hydrocortisone 2.5 % Topical OintmentSY848574fe-a23e-4e15-8c29-d624f50b71de1
103401hydrocortisone 2.5 % Topical OintmentSYf9b498e2-be9d-209f-e053-6394a90a9cc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-014-02458020014021 TUBE in 1 CARTON (45802-014-02) / 20 g in 1 TUBE1 tube2006-06-130000-00-00NoNoCurrent
45802-014-0545802001405454 g in 1 JAR (45802-014-05) 454 g2006-12-190000-00-00NoNoCurrent