bupropion hydrochloride xl

Generic: bupropion hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl
Generic Name bupropion hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-319
Product ID 68180-319_dbdd8397-08cd-4e0a-b545-601a288c195c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090693
Listing Expiration 2026-12-31
Marketing Start 2017-06-14

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 68180319
Hyphenated Format 68180-319

Supplemental Identifiers

RxCUI
993541 993557
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 ANDA090693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-02)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-06)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-09)
source: ndc

Packages (3)

68180-319-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-02) 68180-319-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-06) 68180-319-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-09)

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": "dbdd8397-08cd-4e0a-b545-601a288c195c", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["1af14d2e-c64d-44b7-a402-8869e8e30661"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-02)", "package_ndc": "68180-319-02", "marketing_start_date": "20170614"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-06)", "package_ndc": "68180-319-06", "marketing_start_date": "20170614"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-09)", "package_ndc": "68180-319-09", "marketing_start_date": "20170614"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "68180-319_dbdd8397-08cd-4e0a-b545-601a288c195c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "68180-319", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Lupin Pharmaceuticals, 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": "ANDA090693", "marketing_category": "ANDA", "marketing_start_date": "20170614", "listing_expiration_date": "20261231"}