atomoxetine hydrochloride

Generic: atomoxetine hydrochloride

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

Drug Facts

Product Profile

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

atomoxetine hydrochloride 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4313
Product ID 70518-4313_402dde79-775f-0a84-e063-6294a90a60c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078983
Listing Expiration 2026-12-31
Marketing Start 2025-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184313
Hyphenated Format 70518-4313

Supplemental Identifiers

RxCUI
349591
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 hydrochloride (source: ndc)
Generic Name atomoxetine hydrochloride (source: ndc)
Application Number ANDA078983 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-4313-0) / 1 CAPSULE in 1 POUCH (70518-4313-1)
source: ndc

Packages (1)

70518-4313-0 30 POUCH in 1 BOX (70518-4313-0) / 1 CAPSULE in 1 POUCH (70518-4313-1)

Ingredients (1)

atomoxetine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Atomoxetine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "402dde79-775f-0a84-e063-6294a90a60c0", "openfda": {"unii": ["57WVB6I2W0"], "rxcui": ["349591"], "spl_set_id": ["6d7ea8f7-981c-4acc-aeaf-7516325bfc0c"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-4313-0)  / 1 CAPSULE in 1 POUCH (70518-4313-1)", "package_ndc": "70518-4313-0", "marketing_start_date": "20250319"}], "brand_name": "Atomoxetine Hydrochloride", "product_id": "70518-4313_402dde79-775f-0a84-e063-6294a90a60c0", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "70518-4313", "generic_name": "atomoxetine hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine Hydrochloride", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078983", "marketing_category": "ANDA", "marketing_start_date": "20250319", "listing_expiration_date": "20261231"}