Proctozone

Product NDC
64980-301
11-digit product format
649800301
Labeler code
64980
Product ID
64980-301_0c61d2ad-0795-455a-a720-a81df1a0b0e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA089682
Marketing category
ANDA
Marketing start
2012-05-01
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-301-30GM - Gram64980-301b0cd9ecc-6d12-4b8e-99a8-ff0e9bc0e8ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310891hydrocortisone 2.5 % Topical CreamPSNd7f1f3d3-ce56-43f7-8d3c-3e250fced2d31
1440936Proctozone HC 2.5 % Topical CreamPSNd7f1f3d3-ce56-43f7-8d3c-3e250fced2d31
1440936hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]SBDd7f1f3d3-ce56-43f7-8d3c-3e250fced2d31
310891hydrocortisone 25 MG/ML Topical CreamSCDd7f1f3d3-ce56-43f7-8d3c-3e250fced2d31
310891hydrocortisone 2.5 % Topical CreamSYd7f1f3d3-ce56-43f7-8d3c-3e250fced2d31
1440936Proctozone HC 2.5 % Topical CreamSYd7f1f3d3-ce56-43f7-8d3c-3e250fced2d31
1440936Proctozone HC 25 MG/ML Topical CreamSYd7f1f3d3-ce56-43f7-8d3c-3e250fced2d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-301-30649800301301 TUBE in 1 CARTON (64980-301-30) > 30 g in 1 TUBE1 tube2012-05-010000-00-00NoNoCurrent