atomoxetine

Generic: atomoxetine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atomoxetine hydrochloride 10 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-064
Product ID 42291-064_485b5018-57ec-90d7-e063-6294a90ae5e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079022
Listing Expiration 2027-12-31
Marketing Start 2022-04-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291064
Hyphenated Format 42291-064

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
UPC
0342291066304 0342291069305 0342291068308 0342291064300 0342291070301 0342291067301
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 (source: ndc)
Generic Name atomoxetine (source: ndc)
Application Number ANDA079022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (42291-064-30)
source: ndc

Packages (1)

42291-064-30 30 CAPSULE in 1 BOTTLE (42291-064-30)

Ingredients (1)

atomoxetine hydrochloride (10 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": "485b5018-57ec-90d7-e063-6294a90ae5e2", "openfda": {"upc": ["0342291066304", "0342291069305", "0342291068308", "0342291064300", "0342291070301", "0342291067301"], "unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["dc7ba02c-bdbb-5136-e053-2995a90ac545"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42291-064-30)", "package_ndc": "42291-064-30", "marketing_start_date": "20220412"}], "brand_name": "Atomoxetine", "product_id": "42291-064_485b5018-57ec-90d7-e063-6294a90ae5e2", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "42291-064", "generic_name": "Atomoxetine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA079022", "marketing_category": "ANDA", "marketing_start_date": "20220412", "listing_expiration_date": "20271231"}