FDA.reportPublic FDA data

Hydrocortisone

Product NDC
62559-431
11-digit product format
625590431
Labeler code
62559
Product ID
62559-431_4538e1ca-670f-4800-ae86-1a728e6b029b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA080706
Marketing category
ANDA
Marketing start
2016-04-01
Substance
HYDROCORTISONE
Active strength
25 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui106258, 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
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
62559-431-30Hydrocortisone1 in 1 CARTONCREAM14
62559-431-30Hydrocortisone30 g in 1 TUBECREAM304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-431-30GM - Gram62559-4314c74c5e9-2a69-4d11-ae2b-728a0b7b63fa12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-431HYDROCORTISONE CREAM [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20181220_b2918ac7-14b5-4372-9055-8caf6f4bcf37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310891hydrocortisone 2.5 % Topical CreamPSN3d17e73a-15f5-4881-baf2-47a0149585fd104
310891hydrocortisone 25 MG/ML Topical CreamSCD3d17e73a-15f5-4881-baf2-47a0149585fd104
310891hydrocortisone 2.5 % Topical CreamSY3d17e73a-15f5-4881-baf2-47a0149585fd104
310891hydrocortisone 2.5 % Topical CreamPSN5e95eb82-40cd-411b-9006-c27b65db4b3f102
310891hydrocortisone 25 MG/ML Topical CreamSCD5e95eb82-40cd-411b-9006-c27b65db4b3f102
310891hydrocortisone 2.5 % Topical CreamSY5e95eb82-40cd-411b-9006-c27b65db4b3f102
310891hydrocortisone 2.5 % Topical CreamPSNb6808d2d-192c-4d70-a2e8-bf13375c0280100
310891hydrocortisone 25 MG/ML Topical CreamSCDb6808d2d-192c-4d70-a2e8-bf13375c0280100
310891hydrocortisone 2.5 % Topical CreamSYb6808d2d-192c-4d70-a2e8-bf13375c0280100
310891hydrocortisone 2.5 % Topical CreamPSN5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c17
310891hydrocortisone 25 MG/ML Topical CreamSCD5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c17
310891hydrocortisone 2.5 % Topical CreamSY5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c17
310891hydrocortisone 2.5 % Topical CreamPSN026728d4-846b-4bd4-9183-ae6c4a7141385
310891hydrocortisone 25 MG/ML Topical CreamSCD026728d4-846b-4bd4-9183-ae6c4a7141385
310891hydrocortisone 2.5 % Topical CreamSY026728d4-846b-4bd4-9183-ae6c4a7141385
106258hydrocortisone 1 % Topical CreamPSNb2918ac7-14b5-4372-9055-8caf6f4bcf374
310891hydrocortisone 2.5 % Topical CreamPSNb2918ac7-14b5-4372-9055-8caf6f4bcf374
106258hydrocortisone 10 MG/ML Topical CreamSCDb2918ac7-14b5-4372-9055-8caf6f4bcf374
310891hydrocortisone 25 MG/ML Topical CreamSCDb2918ac7-14b5-4372-9055-8caf6f4bcf374
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYb2918ac7-14b5-4372-9055-8caf6f4bcf374
106258hydrocortisone 1 % Topical CreamSYb2918ac7-14b5-4372-9055-8caf6f4bcf374
106258hydrocortisone 1 GM per 100 GM Topical CreamSYb2918ac7-14b5-4372-9055-8caf6f4bcf374
310891hydrocortisone 2.5 % Topical CreamSYb2918ac7-14b5-4372-9055-8caf6f4bcf374
310891hydrocortisone 2.5 % Topical CreamPSN78f43570-b6fd-42eb-bb9e-580abf79bf0d2
310891hydrocortisone 25 MG/ML Topical CreamSCD78f43570-b6fd-42eb-bb9e-580abf79bf0d2
310891hydrocortisone 2.5 % Topical CreamSY78f43570-b6fd-42eb-bb9e-580abf79bf0d2
310891hydrocortisone 2.5 % Topical CreamPSN1eba8261-0deb-ab6b-e063-6394a90a8d1b1
310891hydrocortisone 25 MG/ML Topical CreamSCD1eba8261-0deb-ab6b-e063-6394a90a8d1b1
310891hydrocortisone 2.5 % Topical CreamSY1eba8261-0deb-ab6b-e063-6394a90a8d1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-431-30625590431301 TUBE in 1 CARTON (62559-431-30) / 30 g in 1 TUBE1 tube2016-04-010000-00-00NoNoCurrent