Econazole Nitrate

Product NDC
0168-0312
11-digit product format
001680312
Labeler code
0168
Product ID
0168-0312_9341ae1f-a59e-497a-9cc7-4dcbdcd59bff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
econazole nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA076075
Marketing category
ANDA
Marketing start
2002-11-26
Marketing end
2020-10-31
Substance
ECONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e3a04dc3-1a9e-4fba-b2b4-a18279351082Product name220180620
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
aa7deb41-117b-479c-8362-130fd1c222deProduct name120160112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0312-15GM - Gram0168-0312823f6007-478b-4462-ab35-04e837bac72812012-07-24
0168-0312-30GM - Gram0168-03125aa7d777-9a23-4b5c-94cd-c0a66b6016f612012-07-24
0168-0312-85GM - Gram0168-0312f0dc6a9e-6011-4f5e-9468-c47c1725cd9b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ECONAZOLE NITRATEACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
ECONAZOLEACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UECONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857366econazole nitrate 1 % Topical CreamPSN050155b7-e8fe-4eee-9516-716399f559f61
857366econazole nitrate 10 MG/ML Topical CreamSCD050155b7-e8fe-4eee-9516-716399f559f61
857366econazole nitrate 1 % Topical CreamSY050155b7-e8fe-4eee-9516-716399f559f61
857366econazole nitrate 10 MG per 1 GM Topical CreamSY050155b7-e8fe-4eee-9516-716399f559f61