This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
  • Home
  • /
  • Drugs
  • /
  • A
  • /
  • Atomoxetine
  • /
  • Atomoxetine ATOMOXETINE HYDROCHLORIDE 60 mg/1 Zydus Lifesciences Limited
FDA Drug information

Atomoxetine

Read time: 1 mins
Marketing start date: 12 Jan 2025
...
 

Summary of product characteristics


Effective Time

20241125

Version

7

Spl Product Data Elements

atomoxetine atomoxetine ATOMOXETINE HYDROCHLORIDE ATOMOXETINE FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE GOLDEN WHITE CAPSULE ZA;68 atomoxetine atomoxetine ATOMOXETINE HYDROCHLORIDE ATOMOXETINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GELATIN POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE OPAQUE BLUE OPAQUE WHITE CAPSULE ZA69;25mg atomoxetine atomoxetine ATOMOXETINE HYDROCHLORIDE ATOMOXETINE FD&C BLUE NO. 2 GELATIN STARCH, CORN SODIUM LAURYL SULFATE TITANIUM DIOXIDE SILICON DIOXIDE SHELLAC PROPYLENE GLYCOL POTASSIUM HYDROXIDE FERROSOFERRIC OXIDE OPAQUE BLUE OPAQUE BLUE CAPSULE ZA70;40mg atomoxetine atomoxetine ATOMOXETINE HYDROCHLORIDE ATOMOXETINE FD&C BLUE NO. 2 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE OPAQUE BLUE GOLDEN CAPSULE ZA71;60mg atomoxetine atomoxetine ATOMOXETINE HYDROCHLORIDE ATOMOXETINE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE OPAQUE BROWN WHITE CAPSULE ZA72;80mg atomoxetine atomoxetine ATOMOXETINE HYDROCHLORIDE ATOMOXETINE FERRIC OXIDE RED FERRIC OXIDE YELLOW GELATIN FERROSOFERRIC OXIDE SODIUM LAURYL SULFATE TITANIUM DIOXIDE SILICON DIOXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC STARCH, CORN OPAQUE BROWN OPAQUE BROWN CAPSULE ZA73;100mg atomoxetine atomoxetine ATOMOXETINE HYDROCHLORIDE ATOMOXETINE AMMONIA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER OPAQUE WHITE OPAQUE WHITE CAPSULE ZA;67;10mg

Application Number

ANDA079017

Brand Name

Atomoxetine

Generic Name

atomoxetine

Product Ndc

65841-609

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-606-16 in bottle of 90 Capsules Atomoxetine Capsules, 18 mg 90 Capsules NDC 65841-607-16 in bottle of 90 Capsules Atomoxetine Capsules, 25 mg 90 Capsules NDC 65841-608-16 in bottle of 90 Capsules Atomoxetine Capsules, 40 mg 90 Capsules NDC 65841-609-16 in bottle of 90 Capsules Atomoxetine Capsules, 60 mg 90 Capsules NDC 65841-610-16 in bottle of 90 Capsules Atomoxetine Capsules, 80 mg 90 Capsules NDC 65841-611-16 in bottle of 90 Capsules Atomoxetine Capsules, 100 mg 90 Capsules NDC 65841-605-16 in bottle of 90 Capsules Atomoxetine Capsules, 10 mg 90 Capsules Atomoxetine 18 mg Atomoxetine 25 mg Atomoxetine 40 mg Atomoxetine 60 mg Atomoxetine 80 mg Atomoxetine caps 100 mg 10 mg label

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.