FDA.reportPublic FDA data

Hydrocortisone

Product NDC
0472-0321
11-digit product format
004720321
Labeler code
0472
Product ID
0472-0321_9c878619-0930-40f2-b1a6-e92328a25fb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA087795
Marketing category
ANDA
Marketing start
2002-01-03
Marketing end
2026-10-31
Substance
HYDROCORTISONE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocortisone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui106258

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-0321-26Hydrocortisone28.4 g in 1 TUBECREAM28.48
0472-0321-26Hydrocortisone1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0321-26GM - Gram0472-03213a6682ec-de0c-4341-9c34-0368d72a4b1412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [STAT RX USA LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [STAT RX USA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE CREAM [STAT RX USA LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE CREAM [STAT RX USA LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [STAT RX USA LLC]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHYDROCORTISONE CREAM [STAT RX USA LLC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE CREAM [STAT RX USA LLC]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [STAT RX USA LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HYDROCORTISONE CREAM [STAT RX USA LLC]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [STAT RX USA LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE CREAM [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0321HYDROCORTISONE CREAM [ACTAVIS PHARMA, INC.]7Current NDC, Legacy NDC, 2 package rows20200811_aa9dba84-eb38-4ec3-8555-87c948bf2384.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNaa9dba84-eb38-4ec3-8555-87c948bf23848
106258hydrocortisone 10 MG/ML Topical CreamSCDaa9dba84-eb38-4ec3-8555-87c948bf23848
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYaa9dba84-eb38-4ec3-8555-87c948bf23848
106258hydrocortisone 1 % Topical CreamSYaa9dba84-eb38-4ec3-8555-87c948bf23848
106258hydrocortisone 1 GM per 100 GM Topical CreamSYaa9dba84-eb38-4ec3-8555-87c948bf23848
106258hydrocortisone 1 % Topical CreamPSNc28c3ceb-1807-b43b-e053-2995a90a2aba3
106258hydrocortisone 10 MG/ML Topical CreamSCDc28c3ceb-1807-b43b-e053-2995a90a2aba3
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYc28c3ceb-1807-b43b-e053-2995a90a2aba3
106258hydrocortisone 1 % Topical CreamSYc28c3ceb-1807-b43b-e053-2995a90a2aba3
106258hydrocortisone 1 GM per 100 GM Topical CreamSYc28c3ceb-1807-b43b-e053-2995a90a2aba3
106258hydrocortisone 1 % Topical CreamPSN556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf1
106258hydrocortisone 1 % Topical CreamPSN1fc033bf-2550-d9ac-e063-6394a90aca751
106258hydrocortisone 10 MG/ML Topical CreamSCD556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf1
106258hydrocortisone 10 MG/ML Topical CreamSCD1fc033bf-2550-d9ac-e063-6394a90aca751
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1fc033bf-2550-d9ac-e063-6394a90aca751
106258hydrocortisone 1 % Topical CreamSY556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf1
106258hydrocortisone 1 % Topical CreamSY1fc033bf-2550-d9ac-e063-6394a90aca751
106258hydrocortisone 1 GM per 100 GM Topical CreamSY556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf1
106258hydrocortisone 1 GM per 100 GM Topical CreamSY1fc033bf-2550-d9ac-e063-6394a90aca751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0321-26004720321261 TUBE in 1 CARTON (0472-0321-26) / 28.4 g in 1 TUBE1 tube2002-01-032026-10-31NoNoCurrent