FDA Product

Econazole Nitrate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Econazole Nitrate

FDA Product Code

63629-8647

Regulatory Information

NDC Product Code

63629-8647

Application Number

ANDA076479

Marketing Category

C73584

Effective Date

July 17, 2023

Territorial Authority

USA

FDA Title

Econazole Nitrate Cream, 1%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

104

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

BUTYLATED HYDROXYANISOLE

Code: REK4960K2U

Class Code: IACT

BENZOIC ACID

Code: 8SKN0B0MIM

Class Code: IACT

MINERAL OIL

Code: T5L8T28FGP

Class Code: IACT

PEG-5 OLEATE

Code: 0240V77G50

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

PEGOXOL 7 STEARATE

Code: 3EW5AXE5X5

Class Code: IACT

ECONAZOLE NITRATE

Quantity: 10 mg in 1 g

Code: H438WYN10E

Class Code: ACTIB

Active Moieties

ECONAZOLE

Code: 6Z1Y2V4A7M

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