aplenzin

Generic: bupropion hydrobromide

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aplenzin
Generic Name bupropion hydrobromide
Labeler bausch health us, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrobromide 348 mg/1

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-5811
Product ID 0187-5811_45372e42-065d-4d87-89af-d5dcf09c29fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022108
Listing Expiration 2027-12-31
Marketing Start 2008-04-23

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 01875811
Hyphenated Format 0187-5811

Supplemental Identifiers

RxCUI
993550 993552 993567 993569 993681 993683
UPC
0301875810306 0301875811303
UNII
E70G3G5863

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 aplenzin (source: ndc)
Generic Name bupropion hydrobromide (source: ndc)
Application Number NDA022108 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 348 mg/1
source: ndc
Packaging
  • 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-07)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-30)
source: ndc

Packages (2)

0187-5811-07 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-07) 0187-5811-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-30)

Ingredients (1)

bupropion hydrobromide (348 mg/1)

Linked Drug Pages (1)

Aplenzin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45372e42-065d-4d87-89af-d5dcf09c29fb", "openfda": {"upc": ["0301875810306", "0301875811303"], "unii": ["E70G3G5863"], "rxcui": ["993550", "993552", "993567", "993569", "993681", "993683"], "spl_set_id": ["6494d2d9-0ce4-4126-b1c7-49684395942b"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-07)", "package_ndc": "0187-5811-07", "marketing_start_date": "20080423"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-30)", "package_ndc": "0187-5811-30", "marketing_start_date": "20080423"}], "brand_name": "Aplenzin", "product_id": "0187-5811_45372e42-065d-4d87-89af-d5dcf09c29fb", "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": "0187-5811", "generic_name": "bupropion hydrobromide", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aplenzin", "active_ingredients": [{"name": "BUPROPION HYDROBROMIDE", "strength": "348 mg/1"}], "application_number": "NDA022108", "marketing_category": "NDA", "marketing_start_date": "20080423", "listing_expiration_date": "20271231"}