atomoxetine

Generic: atomoxetine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine
Generic Name atomoxetine
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 18 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-374
Product ID 64980-374_64643df1-f14e-4f1d-a422-9d7efc2995e2
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 64980374
Hyphenated Format 64980-374

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
UPC
0364980374033 0364980373036 0364980379038 0364980378031 0364980375030 0364980377034 0364980376037
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
  • 18 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (64980-374-03)
source: ndc

Packages (1)

64980-374-03 30 CAPSULE in 1 BOTTLE (64980-374-03)

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": "64643df1-f14e-4f1d-a422-9d7efc2995e2", "openfda": {"upc": ["0364980374033", "0364980373036", "0364980379038", "0364980378031", "0364980375030", "0364980377034", "0364980376037"], "unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["1cceab35-dc4a-40bc-a245-10b64820e217"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (64980-374-03)", "package_ndc": "64980-374-03", "marketing_start_date": "20170530"}], "brand_name": "Atomoxetine", "product_id": "64980-374_64643df1-f14e-4f1d-a422-9d7efc2995e2", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "64980-374", "generic_name": "Atomoxetine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "18 mg/1"}], "application_number": "ANDA079016", "marketing_category": "ANDA", "marketing_start_date": "20170530", "listing_expiration_date": "20261231"}