bupropion hydrochloride

Generic: bupropion hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-738
Product ID 47335-738_b8e6ae63-c5d7-4481-b7b0-17e135670515
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078866
Listing Expiration 2026-12-31
Marketing Start 2020-03-01

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 47335738
Hyphenated Format 47335-738

Supplemental Identifiers

RxCUI
993503 993518 993536
UPC
0347335738865 0347335737868
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 (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA078866 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-08)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-13)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-86)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-88)
source: ndc

Packages (4)

47335-738-08 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-08) 47335-738-13 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-13) 47335-738-86 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-86) 47335-738-88 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-88)

Ingredients (1)

bupropion hydrochloride (200 mg/1)

Linked Drug Pages (1)

Bupropion hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b8e6ae63-c5d7-4481-b7b0-17e135670515", "openfda": {"upc": ["0347335738865", "0347335737868"], "unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["29848192-7de3-4c0d-a822-1268dcf128b0"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-08)", "package_ndc": "47335-738-08", "marketing_start_date": "20200301"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-13)", "package_ndc": "47335-738-13", "marketing_start_date": "20200301"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-86)", "package_ndc": "47335-738-86", "marketing_start_date": "20200301"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-88)", "package_ndc": "47335-738-88", "marketing_start_date": "20200301"}], "brand_name": "Bupropion hydrochloride", "product_id": "47335-738_b8e6ae63-c5d7-4481-b7b0-17e135670515", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "47335-738", "generic_name": "Bupropion hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA078866", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20261231"}