NDC 68071-5104

Duloxetine Delayed-Release

Duloxetine Hydrochloride

Duloxetine Delayed-Release is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Duloxetine Hydrochloride.

Product ID68071-5104_96b3004e-fcda-b524-e053-2a95a90a5b19
NDC68071-5104
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine Delayed-Release
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2014-06-11
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NameNuCare Pharmaceuticals,Inc.
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 Through2020-12-31

Packaging

NDC 68071-5104-9

90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68071-5104-9)
Marketing Start Date2019-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-5104-9 [68071510409]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-06

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

Pharmacological Class

  • Norepinephrine Uptake Inhibitors [MoA]
  • Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
  • Serotonin Uptake Inhibitors [MoA]
  • Norepinephrine Uptake Inhibitors [MoA]
  • Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
  • Serotonin Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Duloxetine Delayed-Release" or generic name "Duloxetine Hydrochloride"

NDCBrand NameGeneric Name
68001-368Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
68788-6380DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
68788-7399DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
68788-9301DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
70518-0122Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
70518-0343Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
70518-1802Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
71335-0509DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
71335-0165DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
71335-0392DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
71610-218Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
43353-025DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
43353-106DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
43353-960DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
45865-815Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
50090-3205Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
50090-3028Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
51991-750Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
51991-746Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
51991-747Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
51991-748Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
55700-505DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
60429-164DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
60429-166DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
60429-165DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
62034-021DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
62034-029DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
63187-702DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
63187-720DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
63187-735DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
64725-0747DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
50090-2226Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
68071-5104Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
0002-3235CymbaltaDuloxetine hydrochloride
0002-3240CymbaltaDuloxetine hydrochloride
0002-3270CymbaltaDuloxetine hydrochloride
21695-145CymbaltaDuloxetine hydrochloride
21695-146CymbaltaDuloxetine hydrochloride
0904-7043DuloxetineDuloxetine Hydrochloride
0904-7044DuloxetineDuloxetine Hydrochloride
0904-7045DuloxetineDuloxetine Hydrochloride
0615-8034Duloxetine HydrochlorideDuloxetine Hydrochloride
0615-8035Duloxetine HydrochlorideDuloxetine Hydrochloride
0904-6452Duloxetine HydrochlorideDuloxetine Hydrochloride
0904-6453Duloxetine HydrochlorideDuloxetine Hydrochloride
0904-6454Duloxetine HydrochlorideDuloxetine Hydrochloride

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.