NDC 65862-453

Duloxetine

Duloxetine Hydrochloride

Duloxetine is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Duloxetine Hydrochloride.

Product ID65862-453_b5add72b-5904-4d55-ad28-b8ef95191653
NDC65862-453
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-12-11
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA090778
Labeler NameAurobindo Pharma Limited
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65862-453-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-30)
Marketing Start Date2013-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-453-99 [65862045399]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-11

NDC 65862-453-78 [65862045378]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11

NDC 65862-453-10 [65862045310]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11

NDC 65862-453-30 [65862045330]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11

NDC 65862-453-90 [65862045390]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11

NDC 65862-453-39 [65862045339]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

NDC Crossover Matching brand name "Duloxetine" or generic name "Duloxetine Hydrochloride"

NDCBrand NameGeneric Name
0093-7542DuloxetineDuloxetine
0093-7543DuloxetineDuloxetine
0093-7544DuloxetineDuloxetine
0228-2890DuloxetineDuloxetine
0228-2891DuloxetineDuloxetine
0228-2892DuloxetineDuloxetine
67877-264DuloxetineDuloxetine
67877-265DuloxetineDuloxetine
67877-263DuloxetineDuloxetine
68001-255DuloxetineDuloxetine
68001-256DuloxetineDuloxetine
68001-257DuloxetineDuloxetine
68071-4700DuloxetineDuloxetine
68084-692DuloxetineDuloxetine
68084-675DuloxetineDuloxetine
68084-683DuloxetineDuloxetine
68151-4727DuloxetineDuloxetine
68180-294DuloxetineDuloxetine
68180-297DuloxetineDuloxetine
68180-295DuloxetineDuloxetine
68180-296DuloxetineDuloxetine
68382-385DuloxetineDuloxetine
68382-386DuloxetineDuloxetine
68382-387DuloxetineDuloxetine
68788-6427duloxetineduloxetine
68788-9262DuloxetineDuloxetine
68788-9266DuloxetineDuloxetine
69097-298duloxetineduloxetine
69097-297duloxetineduloxetine
69097-299duloxetineduloxetine
70518-0491DuloxetineDuloxetine
70518-1066DuloxetineDuloxetine
70518-0937DuloxetineDuloxetine
70518-1054DuloxetineDuloxetine
70518-1139DuloxetineDuloxetine
70518-0685DuloxetineDuloxetine
70518-1128DULOXETINEDULOXETINE
70518-1011DuloxetineDuloxetine
70518-1244DuloxetineDuloxetine
70518-1137DuloxetineDuloxetine
70518-1765DuloxetineDuloxetine
70710-1537DuloxetineDuloxetine
70518-1891DuloxetineDuloxetine
70710-1538DuloxetineDuloxetine
70771-1344DuloxetineDuloxetine
70710-1539DuloxetineDuloxetine
70771-1346DuloxetineDuloxetine
70771-1345DuloxetineDuloxetine
71205-005DuloxetineDuloxetine
71335-0367DuloxetineDuloxetine
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