bupropion hydrochloride xl (70436-011)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl

Generic Name bupropion hydrochloride

Labeler slate run pharmaceuticals, llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer

Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-011

Product ID 70436-011_1b0d6505-54e6-a28f-e063-6294a90aae71

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210015

Listing Expiration 2026-12-31

Marketing Start 2018-12-01

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 70436011

Hyphenated Format 70436-011

Supplemental Identifiers

RxCUI

993541 993557

UPC

0370436010042 0370436011049 0370436011063 0370436010066

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 ANDA210015 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-02)
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-04)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06)

source: ndc

Packages (3)

70436-011-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-02) 70436-011-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-04) 70436-011-06 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06)

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": "1b0d6505-54e6-a28f-e063-6294a90aae71", "openfda": {"upc": ["0370436010042", "0370436011049", "0370436011063", "0370436010066"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["06d4d890-11ed-4f31-8778-c73432e3ea69"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-02)", "package_ndc": "70436-011-02", "marketing_start_date": "20181201"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-04)", "package_ndc": "70436-011-04", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06)", "package_ndc": "70436-011-06", "marketing_start_date": "20181201"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "70436-011_1b0d6505-54e6-a28f-e063-6294a90aae71", "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": "70436-011", "generic_name": "bupropion hydrochloride", "labeler_name": "Slate Run Pharmaceuticals, LLC", "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": "ANDA210015", "marketing_category": "ANDA", "marketing_start_date": "20181201", "listing_expiration_date": "20261231"}