Hydrocortisone

Product NDC
52565-004
11-digit product format
525650004
Labeler code
52565
Product ID
52565-004_4e850fa2-2bb2-4291-9b1d-6f03fcfcf15c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA203810
Marketing category
ANDA
Marketing start
2018-07-23
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
25 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-004-262022-01-28C16284748780-1d6a99b39-d212-a426-e053-dadaa90af4c2HYDROCORTISONE CREAM USP, 2.5% Rx only
52565-004-302022-01-28C16284748780-1d6a99b39-d212-a426-e053-dadaa90af4c2HYDROCORTISONE CREAM USP, 2.5% Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-004-26Hydrocortisone453.6 g in 1 JARCREAM453.63
52565-004-26Hydrocortisone1 in 1 CARTONCREAM13
52565-004-30Hydrocortisone30 g in 1 TUBECREAM303
52565-004-30Hydrocortisone1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-004HYDROCORTISONE CREAM [TELIGENT PHARMA, INC.]3Legacy NDC, 4 package rows20190730_bc7651e9-e7c7-49e0-ad64-36eb50d3eaa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310891hydrocortisone 2.5 % Topical CreamPSNbc7651e9-e7c7-49e0-ad64-36eb50d3eaa23
310891hydrocortisone 25 MG/ML Topical CreamSCDbc7651e9-e7c7-49e0-ad64-36eb50d3eaa23
310891hydrocortisone 2.5 % Topical CreamSYbc7651e9-e7c7-49e0-ad64-36eb50d3eaa23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-004-26525650004261 JAR in 1 CARTON (52565-004-26) > 453.6 g in 1 JAR1 jar2018-07-230000-00-00NoNoCurrent
52565-004-30525650004301 TUBE in 1 CARTON (52565-004-30) > 30 g in 1 TUBE1 tube2018-07-230000-00-00NoNoCurrent