NDC 69238-1380

Difluprednate

Difluprednate Ophthalmic

Difluprednate is a Ophthalmic Emulsion in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Difluprednate.

Product ID69238-1380_e040a0ad-3ac3-4079-9d84-288cfcf4661f
NDC69238-1380
Product TypeHuman Prescription Drug
Proprietary NameDifluprednate
Generic NameDifluprednate Ophthalmic
Dosage FormEmulsion
Route of AdministrationOPHTHALMIC
Marketing Start Date2021-11-18
Marketing CategoryANDA /
Application NumberANDA211526
Labeler NameAmneal Pharmaceuticals NY LLC
Substance NameDIFLUPREDNATE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69238-1380-3

1 BOTTLE in 1 CARTON (69238-1380-3) > 5 mL in 1 BOTTLE
Marketing Start Date2021-11-18
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Difluprednate" or generic name "Difluprednate Ophthalmic"

NDCBrand NameGeneric Name
69097-341DIFLUPREDNATEDIFLUPREDNATE
69238-1380DifluprednateDifluprednate ophthalmic

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