NDC 68382-223

atomoxetine

Atomoxetine

atomoxetine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Atomoxetine Hydrochloride.

Product ID68382-223_78f8fec9-a17f-4a5e-98d5-33358a7a73b3
NDC68382-223
Product TypeHuman Prescription Drug
Proprietary Nameatomoxetine
Generic NameAtomoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA079017
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameATOMOXETINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesNorepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68382-223-02

2000 CAPSULE in 1 BOTTLE (68382-223-02)
Marketing Start Date2017-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-223-06 [68382022306]

atomoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA079017
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-06

NDC 68382-223-10 [68382022310]

atomoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA079017
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-06

NDC 68382-223-02 [68382022302]

atomoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA079017
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-06

NDC 68382-223-16 [68382022316]

atomoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA079017
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-06

NDC 68382-223-14 [68382022314]

atomoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA079017
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-06

Drug Details

Active Ingredients

IngredientStrength
ATOMOXETINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:5f89c7c9-4c25-4ba2-ad90-5aeadb48f214
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349592
  • 349593
  • 349594
  • 349595
  • 608139
  • 608143
    • UPC Code
  • 0368382223166
  • 0368382217165
  • 0368382220165
  • 0368382219169

    • Pharmacological Class

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

    NDC Crossover Matching brand name "atomoxetine" or generic name "Atomoxetine"

    NDCBrand NameGeneric Name
    0093-3542AtomoxetineAtomoxetine
    0093-3543AtomoxetineAtomoxetine
    0093-3544AtomoxetineAtomoxetine
    0093-3545AtomoxetineAtomoxetine
    0093-3546AtomoxetineAtomoxetine
    0093-3547AtomoxetineAtomoxetine
    68382-217atomoxetineatomoxetine
    68382-220atomoxetineatomoxetine
    68382-218atomoxetineatomoxetine
    68382-219atomoxetineatomoxetine
    68382-223atomoxetineatomoxetine
    68382-216atomoxetineatomoxetine
    68462-266atomoxetineatomoxetine
    68462-265atomoxetineatomoxetine
    68462-270atomoxetineatomoxetine
    68462-269atomoxetineatomoxetine
    68462-267atomoxetineatomoxetine
    68462-268atomoxetineatomoxetine
    68462-271atomoxetineatomoxetine
    0093-3548AtomoxetineAtomoxetine
    16714-761atomoxetineatomoxetine
    16714-755atomoxetineatomoxetine
    16714-758atomoxetineatomoxetine
    16714-759atomoxetineatomoxetine
    16714-756atomoxetineatomoxetine
    16714-760atomoxetineatomoxetine
    16714-757atomoxetineatomoxetine
    55111-563AtomoxetineAtomoxetine
    55111-564AtomoxetineAtomoxetine
    55111-520AtomoxetineAtomoxetine
    55111-521AtomoxetineAtomoxetine
    55111-519AtomoxetineAtomoxetine
    55111-522AtomoxetineAtomoxetine
    55111-528AtomoxetineAtomoxetine
    60687-326AtomoxetineAtomoxetine
    64980-375AtomoxetineAtomoxetine
    64980-379AtomoxetineAtomoxetine
    64980-374AtomoxetineAtomoxetine
    64980-376AtomoxetineAtomoxetine
    64980-377AtomoxetineAtomoxetine
    64980-378AtomoxetineAtomoxetine
    64980-373AtomoxetineAtomoxetine
    65862-243AtomoxetineAtomoxetine
    65862-238AtomoxetineAtomoxetine
    65841-608atomoxetineatomoxetine
    65841-607atomoxetineatomoxetine
    65841-610atomoxetineatomoxetine
    65862-239AtomoxetineAtomoxetine
    65862-241AtomoxetineAtomoxetine
    65862-242AtomoxetineAtomoxetine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.