atomoxetine

Generic: atomoxetine

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine
Generic Name atomoxetine
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 40 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-268
Product ID 68462-268_041a1f90-59cd-4a30-9519-a37853af7239
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079019
Listing Expiration 2027-12-31
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 68462268
Hyphenated Format 68462-268

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
UPC
0368462265307 0368462270301 0368462267301 0368462271308 0368462268308 0368462269305 0368462266304
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 ANDA079019 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 2000 CAPSULE in 1 BOTTLE (68462-268-23)
  • 30 CAPSULE in 1 BOTTLE (68462-268-30)
source: ndc

Packages (2)

68462-268-23 2000 CAPSULE in 1 BOTTLE (68462-268-23) 68462-268-30 30 CAPSULE in 1 BOTTLE (68462-268-30)

Ingredients (1)

atomoxetine hydrochloride (40 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": "041a1f90-59cd-4a30-9519-a37853af7239", "openfda": {"upc": ["0368462265307", "0368462270301", "0368462267301", "0368462271308", "0368462268308", "0368462269305", "0368462266304"], "unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["0ab8d905-e890-4e91-a730-3e5d12f5c23f"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2000 CAPSULE in 1 BOTTLE (68462-268-23)", "package_ndc": "68462-268-23", "marketing_start_date": "20170530"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68462-268-30)", "package_ndc": "68462-268-30", "marketing_start_date": "20170530"}], "brand_name": "atomoxetine", "product_id": "68462-268_041a1f90-59cd-4a30-9519-a37853af7239", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "68462-268", "generic_name": "atomoxetine", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA079019", "marketing_category": "ANDA", "marketing_start_date": "20170530", "listing_expiration_date": "20271231"}