atomoxetine

Generic: atomoxetine

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atomoxetine
Generic Name atomoxetine
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atomoxetine hydrochloride 40 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-218
Product ID 68382-218_8e543a65-7611-4362-94ba-0b3f929c776c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079017
Listing Expiration 2026-12-31
Marketing Start 2017-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382218
Hyphenated Format 68382-218

Supplemental Identifiers

RxCUI
349591 349592 349593 349594 349595 608139 608143
UPC
0368382215161
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 ANDA079017 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 2000 CAPSULE in 1 BOTTLE (68382-218-02)
  • 30 CAPSULE in 1 BOTTLE (68382-218-06)
  • 1000 CAPSULE in 1 BOTTLE (68382-218-10)
  • 60 CAPSULE in 1 BOTTLE (68382-218-14)
  • 90 CAPSULE in 1 BOTTLE (68382-218-16)
  • 10 BLISTER PACK in 1 CARTON (68382-218-77) / 10 CAPSULE in 1 BLISTER PACK (68382-218-30)
source: ndc

Packages (6)

68382-218-02 2000 CAPSULE in 1 BOTTLE (68382-218-02) 68382-218-06 30 CAPSULE in 1 BOTTLE (68382-218-06) 68382-218-10 1000 CAPSULE in 1 BOTTLE (68382-218-10) 68382-218-14 60 CAPSULE in 1 BOTTLE (68382-218-14) 68382-218-16 90 CAPSULE in 1 BOTTLE (68382-218-16) 68382-218-77 10 BLISTER PACK in 1 CARTON (68382-218-77) / 10 CAPSULE in 1 BLISTER PACK (68382-218-30)

Ingredients (1)

atomoxetine hydrochloride (40 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": "8e543a65-7611-4362-94ba-0b3f929c776c", "openfda": {"upc": ["0368382215161"], "unii": ["57WVB6I2W0"], "rxcui": ["349591", "349592", "349593", "349594", "349595", "608139", "608143"], "spl_set_id": ["5f89c7c9-4c25-4ba2-ad90-5aeadb48f214"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2000 CAPSULE in 1 BOTTLE (68382-218-02)", "package_ndc": "68382-218-02", "marketing_start_date": "20170612"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-218-06)", "package_ndc": "68382-218-06", "marketing_start_date": "20170612"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (68382-218-10)", "package_ndc": "68382-218-10", "marketing_start_date": "20170612"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68382-218-14)", "package_ndc": "68382-218-14", "marketing_start_date": "20170612"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68382-218-16)", "package_ndc": "68382-218-16", "marketing_start_date": "20170612"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-218-77)  / 10 CAPSULE in 1 BLISTER PACK (68382-218-30)", "package_ndc": "68382-218-77", "marketing_start_date": "20170612"}], "brand_name": "atomoxetine", "product_id": "68382-218_8e543a65-7611-4362-94ba-0b3f929c776c", "dosage_form": "CAPSULE", "pharm_class": ["Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "68382-218", "generic_name": "atomoxetine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atomoxetine", "active_ingredients": [{"name": "ATOMOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA079017", "marketing_category": "ANDA", "marketing_start_date": "20170612", "listing_expiration_date": "20261231"}