FDA.reportPublic FDA data

Ultravate

Product NDC
10631-102
11-digit product format
106310102
Labeler code
10631
Product ID
10631-102_cd9a3fc1-f9e4-4ab7-9c75-50ab9c65e270
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
halobetasol propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Ranbaxy Laboratories Inc.
Application
NDA019968
Marketing category
NDA
Marketing start
2009-02-20
Marketing end
0000-00-00
Substance
HALOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
9314f950-fe47-4276-b1f9-66d9d4a64eaeProduct name120220217
0bc08e12-b8ed-4802-abab-926d5509afb3Product name120210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
608e9379-3a63-4bf4-b035-b393ae8faa97Product name120190214
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3Product name120151123
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9badac54-f0c2-d87e-de70-c4ea0b9cf6a2Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ee2f33ab-1561-3107-e994-434cb17b4d06Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10631-102-15GM - Gram10631-1027b03fd1d-cdfe-4cb9-af00-986a71a4c53d12015-10-02
10631-102-50GM - Gram10631-102e65ace15-9e11-4c99-93cd-3384aaddefcd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIUM LACTATEACTIVE INGREDIENT67M901L9NQULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
HALOBETASOL PROPIONATEACTIVE INGREDIENT91A0K1TY3ZULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
AMMONIUM CATIONACTIVE MOIETY54S68520I4ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
HALOBETASOLACTIVE MOIETY9P6159HM7TULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HMULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
CETEARYL ISONONANOATEINACTIVE INGREDIENTP5O01U99NIULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
MONOSTEARYL CITRATEINACTIVE INGREDIENTYWW937R1QRULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
PENTAERYTHRITOLINACTIVE INGREDIENTSU420W1S6NULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
STRONTIUM NITRATEINACTIVE INGREDIENTBDG873AQZLULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
TRICAPRYLININACTIVE INGREDIENT6P92858988ULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VULTRAVATE X (HALOBETASOL PROPIONATE) KIT [RANBAXY LABORATORIES INC.]1