atomoxetine hydrochloride

Generic: atomoxetine hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine hydrochloride
Generic Name atomoxetine hydrochloride
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 18 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-2831
Product ID 60505-2831_ad1d5a70-74b7-c5db-b589-88081ba704f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078983
Listing Expiration 2026-12-31
Marketing Start 2018-05-21

Pharmacologic Class

Classes
norepinephrine reuptake inhibitor [epc] norepinephrine uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605052831
Hyphenated Format 60505-2831

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
UNII
57WVB6I2W0

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name atomoxetine hydrochloride (source: ndc)
Generic Name atomoxetine hydrochloride (source: ndc)
Application Number ANDA078983 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (60505-2831-3)
source: ndc

Packages (1)

60505-2831-3 30 CAPSULE in 1 BOTTLE (60505-2831-3)

Ingredients (1)

atomoxetine hydrochloride (18 mg/1)

Linked Drug Pages (1)

Atomoxetine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ad1d5a70-74b7-c5db-b589-88081ba704f9", "openfda": {"unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["132852a6-5bff-15dd-255c-98309dd83630"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (60505-2831-3)", "package_ndc": "60505-2831-3", "marketing_start_date": "20180521"}], "brand_name": "Atomoxetine Hydrochloride", "product_id": "60505-2831_ad1d5a70-74b7-c5db-b589-88081ba704f9", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "60505-2831", "generic_name": "atomoxetine hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine Hydrochloride", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "18 mg/1"}], "application_number": "ANDA078983", "marketing_category": "ANDA", "marketing_start_date": "20180521", "listing_expiration_date": "20261231"}