FDA.reportPublic FDA data

Cortifoam

Product NDC
0037-6830
11-digit product format
000376830
Labeler code
0037
Product ID
0037-6830_c53f12f0-249b-4462-b669-b9ae2b626051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone acetate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Viatris Specialty LLC
Application
NDA017351
Marketing category
NDA
Marketing start
2015-06-15
Substance
HYDROCORTISONE ACETATE
Active strength
1500 mg/15g
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
Cortifoam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE1500 mg/15g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74
Rxcui1545172, 1545174

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0037-6830-15Cortifoam15 g in 1 CANISTERAEROSOL, FOAM1510
0037-6830-15Cortifoam1 in 1 CARTONAEROSOL, FOAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-6830-15GM - Gram0037-6830f5b82942-098c-47d6-a974-ee1bdff0023812015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJCORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
ETHYLENE DISTEARAMIDEINACTIVE INGREDIENT603RP8TB9ACORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
ISOBUTANEINACTIVE INGREDIENTBXR49TP611CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PROPANEINACTIVE INGREDIENTT75W9911L6CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
STEARETH-10INACTIVE INGREDIENTFD0913P475CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKCORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RCORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-6830CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20250309_0093b694-9fcb-46ae-b1ab-7d0fa204c6c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545174cortifoam 10 % Rectal FoamPSN0093b694-9fcb-46ae-b1ab-7d0fa204c6c810
1545172hydrocortisone acetate 10 % Rectal FoamPSN0093b694-9fcb-46ae-b1ab-7d0fa204c6c810
1545174hydrocortisone acetate 100 MG/ML Rectal Foam [Cortifoam]SBD0093b694-9fcb-46ae-b1ab-7d0fa204c6c810
1545172hydrocortisone acetate 100 MG/ML Rectal FoamSCD0093b694-9fcb-46ae-b1ab-7d0fa204c6c810
1545174Cortifoam 10 % Rectal FoamSY0093b694-9fcb-46ae-b1ab-7d0fa204c6c810
1545174Cortifoam 100 MG/ML Rectal FoamSY0093b694-9fcb-46ae-b1ab-7d0fa204c6c810
1545172hydrocortisone acetate 10 % Rectal FoamSY0093b694-9fcb-46ae-b1ab-7d0fa204c6c810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-6830-15000376830151 CANISTER in 1 CARTON (0037-6830-15) / 15 g in 1 CANISTER1 canister2015-06-150000-00-00NoNoCurrent