atomoxetine hydrochloride

Generic: atomoxetine hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine hydrochloride
Generic Name atomoxetine hydrochloride
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 25 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-057
Product ID 50268-057_47e225fb-3d2a-4f80-e063-6394a90aff85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078983
Listing Expiration 2027-12-31
Marketing Start 2020-02-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268057
Hyphenated Format 50268-057

Supplemental Identifiers

RxCUI
349593 349594
UNII
57WVB6I2W0

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
  • 25 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-057-13) / 1 CAPSULE in 1 BLISTER PACK (50268-057-11)
source: ndc

Packages (1)

50268-057-13 30 BLISTER PACK in 1 BOX (50268-057-13) / 1 CAPSULE in 1 BLISTER PACK (50268-057-11)

Ingredients (1)

atomoxetine hydrochloride (25 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": "47e225fb-3d2a-4f80-e063-6394a90aff85", "openfda": {"unii": ["57WVB6I2W0"], "rxcui": ["349593", "349594"], "spl_set_id": ["9e787cc2-5d0f-f231-e053-2a95a90ae99a"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-057-13)  / 1 CAPSULE in 1 BLISTER PACK (50268-057-11)", "package_ndc": "50268-057-13", "marketing_start_date": "20200213"}], "brand_name": "Atomoxetine Hydrochloride", "product_id": "50268-057_47e225fb-3d2a-4f80-e063-6394a90aff85", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "50268-057", "generic_name": "atomoxetine hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine Hydrochloride", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA078983", "marketing_category": "ANDA", "marketing_start_date": "20200213", "listing_expiration_date": "20271231"}