atomoxetine

Generic: atomoxetine

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

Drug Facts

Product Profile

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

atomoxetine hydrochloride 25 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-240
Product ID 65862-240_48d5f73a-bdcc-466a-aa17-53c0a38c3b3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079016
Listing Expiration 2026-12-31
Marketing Start 2017-05-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862240
Hyphenated Format 65862-240

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
UPC
0365862239303 0365862238306 0365862240309 0365862242303 0365862241306
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 ANDA079016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 2000 CAPSULE in 1 BOTTLE (65862-240-22)
  • 30 CAPSULE in 1 BOTTLE (65862-240-30)
source: ndc

Packages (2)

65862-240-22 2000 CAPSULE in 1 BOTTLE (65862-240-22) 65862-240-30 30 CAPSULE in 1 BOTTLE (65862-240-30)

Ingredients (1)

atomoxetine hydrochloride (25 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": "48d5f73a-bdcc-466a-aa17-53c0a38c3b3f", "openfda": {"upc": ["0365862239303", "0365862238306", "0365862240309", "0365862242303", "0365862241306"], "unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["6f6bea0c-297b-43ff-8960-ecc11243e06e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2000 CAPSULE in 1 BOTTLE (65862-240-22)", "package_ndc": "65862-240-22", "marketing_start_date": "20170530"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65862-240-30)", "package_ndc": "65862-240-30", "marketing_start_date": "20170530"}], "brand_name": "Atomoxetine", "product_id": "65862-240_48d5f73a-bdcc-466a-aa17-53c0a38c3b3f", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "65862-240", "generic_name": "Atomoxetine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA079016", "marketing_category": "ANDA", "marketing_start_date": "20170530", "listing_expiration_date": "20261231"}