atomoxetine

Generic: atomoxetine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine
Generic Name atomoxetine
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4337
Product ID 70518-4337_4030d12b-a63d-6c7e-e063-6394a90a7941
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090609
Listing Expiration 2026-12-31
Marketing Start 2025-05-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184337
Hyphenated Format 70518-4337

Supplemental Identifiers

RxCUI
608139
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 ANDA090609 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-4337-0) / 1 CAPSULE in 1 POUCH (70518-4337-1)
source: ndc

Packages (1)

70518-4337-0 30 POUCH in 1 BOX (70518-4337-0) / 1 CAPSULE in 1 POUCH (70518-4337-1)

Ingredients (1)

atomoxetine hydrochloride (100 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": "4030d12b-a63d-6c7e-e063-6394a90a7941", "openfda": {"unii": ["57WVB6I2W0"], "rxcui": ["608139"], "spl_set_id": ["d7002d75-edad-4141-91bf-7eebf50ad1aa"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-4337-0)  / 1 CAPSULE in 1 POUCH (70518-4337-1)", "package_ndc": "70518-4337-0", "marketing_start_date": "20250512"}], "brand_name": "Atomoxetine", "product_id": "70518-4337_4030d12b-a63d-6c7e-e063-6394a90a7941", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "70518-4337", "generic_name": "Atomoxetine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA090609", "marketing_category": "ANDA", "marketing_start_date": "20250512", "listing_expiration_date": "20261231"}