bupropion hydrochloride (xl)

Generic: bupropion hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)
Generic Name bupropion hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-112
Product ID 72789-112_314433f7-d500-d878-e063-6394a90adb5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210081
Listing Expiration 2026-12-31
Marketing Start 2018-08-30

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 72789112
Hyphenated Format 72789-112

Supplemental Identifiers

RxCUI
993557
UPC
0372789112909
UNII
ZG7E5POY8O

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 ANDA210081 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-112-90)
source: ndc

Packages (1)

72789-112-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-112-90)

Ingredients (1)

bupropion hydrochloride (300 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": "314433f7-d500-d878-e063-6394a90adb5b", "openfda": {"upc": ["0372789112909"], "unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["d017f3dc-3688-487f-9130-808b33976b22"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-112-90)", "package_ndc": "72789-112-90", "marketing_start_date": "20200903"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "72789-112_314433f7-d500-d878-e063-6394a90adb5b", "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": "72789-112", "generic_name": "bupropion hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "(XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA210081", "marketing_category": "ANDA", "marketing_start_date": "20180830", "listing_expiration_date": "20261231"}