FDA.reportPublic FDA data

hydrocortisone acetate pramoxine hcl

Product NDC
45802-144
11-digit product format
458020144
Labeler code
45802
Product ID
45802-144_d2d16487-bf77-4da4-8fa8-3cf8dd1b98b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone acetate pramoxine hcl
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA085368
Marketing category
ANDA
Marketing start
2010-04-13
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
1; 1 g/100g; g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
hydrocortisone acetate pramoxine hcl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE1 g/100g
PRAMOXINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, 88AYB867L5
Rxcui1235049

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-144-64hydrocortisone acetate pramoxine hcl1 in 1 CARTONCREAM15
45802-144-64hydrocortisone acetate pramoxine hcl28.35 g in 1 TUBECREAM28.355

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-144-64GM - Gram45802-1441d40c8cd-39cd-4587-8825-dd410e93aafc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
PRAMOXINEACTIVE MOIETY068X84E056HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
TROLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAAHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-144HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 2 package rows20241218_9eea5875-d153-4bba-aee2-b1d1cd8b5e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235049hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN3c5e1833-9908-4e4f-bdf2-7a28c14a585c104
1235049hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD3c5e1833-9908-4e4f-bdf2-7a28c14a585c104
1235049hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY3c5e1833-9908-4e4f-bdf2-7a28c14a585c104
1235049hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN0c28458a-cc56-4eea-89aa-d60659bd9568100
1235049hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD0c28458a-cc56-4eea-89aa-d60659bd9568100
1235049hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY0c28458a-cc56-4eea-89aa-d60659bd9568100
1235049hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN9eea5875-d153-4bba-aee2-b1d1cd8b5e575
1235049hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD9eea5875-d153-4bba-aee2-b1d1cd8b5e575
1235049hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY9eea5875-d153-4bba-aee2-b1d1cd8b5e575

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-144-64458020144641 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE1 tube2010-04-130000-00-00NoNoCurrent