bupropion hcl er (xl)

Generic: bupropion hcl er (xl)

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hcl er (xl)
Generic Name bupropion hcl er (xl)
Labeler direct_rx
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-558
Product ID 61919-558_4c4a1599-23d9-4beb-e063-6294a90a2c6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090693
Listing Expiration 2027-12-31
Marketing Start 2024-02-15

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 61919558
Hyphenated Format 61919-558

Supplemental Identifiers

RxCUI
993541
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 hcl er (xl) (source: ndc)
Generic Name bupropion hcl er (xl) (source: ndc)
Application Number ANDA090693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-60)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-72)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-90)
source: ndc

Packages (3)

61919-558-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-60) 61919-558-72 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-72) 61919-558-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-90)

Ingredients (1)

bupropion hydrochloride (150 mg/1)

Linked Drug Pages (1)

Bupropion HCL ER (XL) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c4a1599-23d9-4beb-e063-6294a90a2c6b", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541"], "spl_set_id": ["116cc898-66d6-e3a9-e063-6294a90a67fb"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-60)", "package_ndc": "61919-558-60", "marketing_start_date": "20240215"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-72)", "package_ndc": "61919-558-72", "marketing_start_date": "20240215"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-90)", "package_ndc": "61919-558-90", "marketing_start_date": "20240215"}], "brand_name": "Bupropion HCL ER (XL)", "product_id": "61919-558_4c4a1599-23d9-4beb-e063-6294a90a2c6b", "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": "61919-558", "generic_name": "Bupropion HCL ER (XL)", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion HCL ER (XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA090693", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20271231"}