atomoxetine

Generic: atomoxetine

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine
Generic Name atomoxetine
Labeler strides pharma science limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 18 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-473
Product ID 64380-473_27a196c2-92d8-4c4f-97e5-210ae78dedbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079021
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380473
Hyphenated Format 64380-473

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
UPC
0364380477013 0364380475019 0364380478010 0364380474012 0364380472018 0364380476016 0364380473015
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 (source: ndc)
Generic Name atomoxetine (source: ndc)
Application Number ANDA079021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-01)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-02)
source: ndc

Packages (2)

64380-473-01 30 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-01) 64380-473-02 500 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-02)

Ingredients (1)

atomoxetine hydrochloride (18 mg/1)

Linked Drug Pages (1)

Atomoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27a196c2-92d8-4c4f-97e5-210ae78dedbe", "openfda": {"upc": ["0364380477013", "0364380475019", "0364380478010", "0364380474012", "0364380472018", "0364380476016", "0364380473015"], "unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["2614df7e-0b16-4b03-883e-141d4ec34b35"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-01)", "package_ndc": "64380-473-01", "marketing_start_date": "20250701"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-02)", "package_ndc": "64380-473-02", "marketing_start_date": "20250701"}], "brand_name": "Atomoxetine", "product_id": "64380-473_27a196c2-92d8-4c4f-97e5-210ae78dedbe", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "64380-473", "generic_name": "Atomoxetine", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "18 mg/1"}], "application_number": "ANDA079021", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}