atomoxetine

Generic: atomoxetine

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine
Generic Name atomoxetine
Labeler dr. reddy's laboratories limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 25 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-528
Product ID 55111-528_d266ad8b-af60-8e42-149b-e881323543a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090609
Listing Expiration 2026-12-31
Marketing Start 2018-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111528
Hyphenated Format 55111-528

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
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 ANDA090609 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (55111-528-05)
  • 30 CAPSULE in 1 BOTTLE (55111-528-30)
  • 100 BLISTER PACK in 1 CARTON (55111-528-78) / 10 CAPSULE in 1 BLISTER PACK (55111-528-79)
source: ndc

Packages (3)

55111-528-05 500 CAPSULE in 1 BOTTLE (55111-528-05) 55111-528-30 30 CAPSULE in 1 BOTTLE (55111-528-30) 55111-528-78 100 BLISTER PACK in 1 CARTON (55111-528-78) / 10 CAPSULE in 1 BLISTER PACK (55111-528-79)

Ingredients (1)

atomoxetine hydrochloride (25 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": "d266ad8b-af60-8e42-149b-e881323543a5", "openfda": {"unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["973bdc9b-6421-7e00-e2b6-3cce036d363e"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (55111-528-05)", "package_ndc": "55111-528-05", "marketing_start_date": "20180223"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (55111-528-30)", "package_ndc": "55111-528-30", "marketing_start_date": "20180223"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (55111-528-78)  / 10 CAPSULE in 1 BLISTER PACK (55111-528-79)", "package_ndc": "55111-528-78", "marketing_start_date": "20180223"}], "brand_name": "Atomoxetine", "product_id": "55111-528_d266ad8b-af60-8e42-149b-e881323543a5", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "55111-528", "generic_name": "Atomoxetine", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA090609", "marketing_category": "ANDA", "marketing_start_date": "20180223", "listing_expiration_date": "20261231"}