metoprolol succinate

Generic: metoprolol succinate

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metoprolol succinate
Generic Name metoprolol succinate
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metoprolol succinate 100 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-115
Product ID 82009-115_65151fb6-9d77-fb5b-bde1-8d78322e4a1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078889
Listing Expiration 2026-12-31
Marketing Start 2023-07-20

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009115
Hyphenated Format 82009-115

Supplemental Identifiers

RxCUI
866412 866419
UPC
0382009116051 0382009115054
UNII
TH25PD4CCB

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 metoprolol succinate (source: ndc)
Generic Name metoprolol succinate (source: ndc)
Application Number ANDA078889 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82009-115-05)
source: ndc

Packages (1)

82009-115-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82009-115-05)

Ingredients (1)

metoprolol succinate (100 mg/1)

Linked Drug Pages (1)

Metoprolol succinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "65151fb6-9d77-fb5b-bde1-8d78322e4a1a", "openfda": {"upc": ["0382009116051", "0382009115054"], "unii": ["TH25PD4CCB"], "rxcui": ["866412", "866419"], "spl_set_id": ["e147a897-4a23-1e1a-73cd-f2e6c9a7280d"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82009-115-05)", "package_ndc": "82009-115-05", "marketing_start_date": "20230720"}], "brand_name": "Metoprolol succinate", "product_id": "82009-115_65151fb6-9d77-fb5b-bde1-8d78322e4a1a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "82009-115", "generic_name": "Metoprolol succinate", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metoprolol succinate", "active_ingredients": [{"name": "METOPROLOL SUCCINATE", "strength": "100 mg/1"}], "application_number": "ANDA078889", "marketing_category": "ANDA", "marketing_start_date": "20230720", "listing_expiration_date": "20261231"}