FDA.reportPublic FDA data

Hydrocortisone Butyrate

Product NDC
52565-087
11-digit product format
525650087
Labeler code
52565
Product ID
52565-087_a0963357-1034-43ee-81bb-9c249fa29de3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE BUTYRATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209556
Marketing category
ANDA
Marketing start
2017-11-21
Marketing end
0000-00-00
Substance
HYDROCORTISONE BUTYRATE
Active strength
1 mg/mL
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
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-087-022023-01-30C16284748780-1f386c64a-4698-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HYDROCORTISONE BUTYRATE safely and effectively. See full prescribing information for HYDROCORTISONE BUTYRATE. Hydrocortisone Butyrate Lotion, 0.1%, for topical use Initial U.S. Approval: 1982
52565-087-042023-01-30C16284748780-1f386c64a-4698-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HYDROCORTISONE BUTYRATE safely and effectively. See full prescribing information for HYDROCORTISONE BUTYRATE. Hydrocortisone Butyrate Lotion, 0.1%, for topical use Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-087-02Hydrocortisone Butyrate59 mL in 1 BOTTLELOTION592
52565-087-02Hydrocortisone Butyrate1 in 1 CARTONLOTION12
52565-087-04Hydrocortisone Butyrate1 in 1 CARTONLOTION12
52565-087-04Hydrocortisone Butyrate118 mL in 1 BOTTLELOTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-087-02ML - Milliliter52565-0872ada8c3c-6a15-41bd-af2c-b7656802445012018-03-08
52565-087-04ML - Milliliter52565-087568f1546-4980-43a8-a809-2f64c671906912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-087HYDROCORTISONE BUTYRATE (HYDROCORTISONE BUTYRATE) LOTION [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190911_97d35248-b28b-18b0-98a6-2d93476fb4a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370763hydrocortisone butyrate 0.1 % Topical LotionPSN97d35248-b28b-18b0-98a6-2d93476fb4a32
1370763hydrocortisone butyrate 1 MG/ML Topical LotionSCD97d35248-b28b-18b0-98a6-2d93476fb4a32
1370763hydrocortisone butyrate 0.1 % Topical LotionSY97d35248-b28b-18b0-98a6-2d93476fb4a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-087-02525650087021 BOTTLE in 1 CARTON (52565-087-02) > 59 mL in 1 BOTTLE1 bottle2017-11-210000-00-00NoNoCurrent
52565-087-04525650087041 BOTTLE in 1 CARTON (52565-087-04) > 118 mL in 1 BOTTLE1 bottle2017-11-210000-00-00NoNoCurrent