Procto-Med HC

Product NDC
69315-302
11-digit product format
693150302
Labeler code
69315
Product ID
69315-302_d4bcf8db-c5e5-42d5-96b2-d5df7ed50555
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Leading Pharma, LLC
Application
ANDA089682
Marketing category
ANDA
Marketing start
2016-05-09
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69315-302-302023-01-30C16284748780-1f386c64a-3cfe-0266-e053-dadaa90a7c1aHYDROCORTISONE CREAM USP, 2.5% FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-302-30Procto-Med HC1 in 1 CARTONCREAM14
69315-302-30Procto-Med HC30 g in 1 TUBECREAM304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-302-30GM - Gram69315-302f5f16eda-fe96-44cd-b871-2557c2c619cc12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-302PROCTO-MED HC (HYDROCORTISONE) CREAM [LEADING PHARMA, LLC]4Legacy NDC, 2 package rows20171213_8548507e-616b-4ea6-bcc4-5cafd0a4b2e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310891hydrocortisone 2.5 % Topical CreamPSN70a7d1b6-a460-43c9-8aed-519f0cdd558b9
1790684Procto-Med HC 2.5 % Topical CreamPSN70a7d1b6-a460-43c9-8aed-519f0cdd558b9
1790684hydrocortisone 25 MG/ML Topical Cream [Procto-Med]SBD70a7d1b6-a460-43c9-8aed-519f0cdd558b9
310891hydrocortisone 25 MG/ML Topical CreamSCD70a7d1b6-a460-43c9-8aed-519f0cdd558b9
310891hydrocortisone 2.5 % Topical CreamSY70a7d1b6-a460-43c9-8aed-519f0cdd558b9
1790684Procto-Med HC 2.5 % Topical CreamSY70a7d1b6-a460-43c9-8aed-519f0cdd558b9
310891hydrocortisone 2.5 % Topical CreamPSN8548507e-616b-4ea6-bcc4-5cafd0a4b2e64
1790684Procto-Med HC 2.5 % Topical CreamPSN8548507e-616b-4ea6-bcc4-5cafd0a4b2e64
1790684hydrocortisone 25 MG/ML Topical Cream [Procto-Med]SBD8548507e-616b-4ea6-bcc4-5cafd0a4b2e64
310891hydrocortisone 25 MG/ML Topical CreamSCD8548507e-616b-4ea6-bcc4-5cafd0a4b2e64
310891hydrocortisone 2.5 % Topical CreamSY8548507e-616b-4ea6-bcc4-5cafd0a4b2e64
1790684Procto-Med HC 2.5 % Topical CreamSY8548507e-616b-4ea6-bcc4-5cafd0a4b2e64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-302-30693150302301 TUBE in 1 CARTON (69315-302-30) > 30 g in 1 TUBE1 tube2016-05-090000-00-00NoNoCurrent