bupropion hydrochloride xl

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl
Generic Name bupropion hydrochloride
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3331
Product ID 0591-3331_08ef0752-1fcf-418b-9b72-3fbab8b23058
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077715
Listing Expiration 2027-12-31
Marketing Start 2008-11-26

Pharmacologic Class

Classes
aminoketone [epc] dopamine uptake inhibitors [moa] increased dopamine activity [pe] increased norepinephrine activity [pe] norepinephrine uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913331
Hyphenated Format 0591-3331

Supplemental Identifiers

RxCUI
993541
UNII
ZG7E5POY8O

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 bupropion hydrochloride xl (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA077715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-05)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-19)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-30)
source: ndc

Packages (3)

0591-3331-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-05) 0591-3331-19 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-19) 0591-3331-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-30)

Ingredients (1)

bupropion hydrochloride (150 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride XL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "08ef0752-1fcf-418b-9b72-3fbab8b23058", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541"], "spl_set_id": ["a1e768fd-c28f-4b49-822d-ccc315b4099c"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-05)", "package_ndc": "0591-3331-05", "marketing_start_date": "20081126"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-19)", "package_ndc": "0591-3331-19", "marketing_start_date": "20081126"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-30)", "package_ndc": "0591-3331-30", "marketing_start_date": "20081126"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "0591-3331_08ef0752-1fcf-418b-9b72-3fbab8b23058", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "0591-3331", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "XL", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA077715", "marketing_category": "ANDA", "marketing_start_date": "20081126", "listing_expiration_date": "20271231"}