bupropion hydrochloride (xl)

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)
Generic Name bupropion hydrochloride
Labeler lannett company inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Lannett Company Inc.

Identifiers & Regulatory

Product NDC 0527-2415
Product ID 0527-2415_5e3c0247-0f79-454e-b14d-1e7dfd1a765e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208652
Listing Expiration 2027-12-31
Marketing Start 2018-01-08

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 05272415
Hyphenated Format 0527-2415

Supplemental Identifiers

RxCUI
993541 993557
UPC
0305272430419 0305272415461 0305272430464 0305272415416 0305272430327 0305272430433 0305272415324 0305272415430
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 ANDA208652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-32)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-41)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-43)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-46)
source: ndc

Packages (4)

0527-2415-32 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-32) 0527-2415-41 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-41) 0527-2415-43 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-43) 0527-2415-46 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-46)

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": "5e3c0247-0f79-454e-b14d-1e7dfd1a765e", "openfda": {"upc": ["0305272430419", "0305272415461", "0305272430464", "0305272415416", "0305272430327", "0305272430433", "0305272415324", "0305272415430"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["15c4e95a-d203-4caf-b6c7-44792355cb76"], "manufacturer_name": ["Lannett Company Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-32)", "package_ndc": "0527-2415-32", "marketing_start_date": "20220131"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-41)", "package_ndc": "0527-2415-41", "marketing_start_date": "20220131"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-43)", "package_ndc": "0527-2415-43", "marketing_start_date": "20220131"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-46)", "package_ndc": "0527-2415-46", "marketing_start_date": "20220131"}], "brand_name": "Bupropion hydrochloride (XL)", "product_id": "0527-2415_5e3c0247-0f79-454e-b14d-1e7dfd1a765e", "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": "0527-2415", "generic_name": "Bupropion hydrochloride", "labeler_name": "Lannett Company Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion hydrochloride (XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA208652", "marketing_category": "ANDA", "marketing_start_date": "20180108", "listing_expiration_date": "20271231"}