rybelsus

Generic: oral semaglutide

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rybelsus
Generic Name oral semaglutide
Labeler novo nordisk
Dosage Form TABLET
Routes
ORAL
Active Ingredients

semaglutide 3 mg/1

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-4303
Product ID 0169-4303_dfe441cd-c20f-452b-a8a5-3a6017b6b006
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213051
Listing Expiration 2027-12-31
Marketing Start 2019-09-20

Pharmacologic Class

Established (EPC)
glp-1 receptor agonist [epc]
Mechanism of Action
glucagon-like peptide-1 (glp-1) agonists [moa]
Chemical Structure
glucagon-like peptide 1 [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01694303
Hyphenated Format 0169-4303

Supplemental Identifiers

RxCUI
2200644 2200650 2200652 2200654 2200656 2200658 2707547 2707549 2707551 2707553 2707555 2707557 2736944 2736946 2736948
UNII
53AXN4NNHX
NUI
N0000178480 M0160181 N0000020058

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 rybelsus (source: ndc)
Generic Name oral semaglutide (source: ndc)
Application Number NDA213051 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, GLASS (0169-4303-30)
  • 30 TABLET in 1 BOTTLE, GLASS (0169-4303-99)
source: ndc

Packages (2)

0169-4303-30 30 TABLET in 1 BOTTLE, GLASS (0169-4303-30) 0169-4303-99 30 TABLET in 1 BOTTLE, GLASS (0169-4303-99)

Ingredients (1)

semaglutide (3 mg/1)

Linked Drug Pages (1)

RYBELSUS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dfe441cd-c20f-452b-a8a5-3a6017b6b006", "openfda": {"nui": ["N0000178480", "M0160181", "N0000020058"], "unii": ["53AXN4NNHX"], "rxcui": ["2200644", "2200650", "2200652", "2200654", "2200656", "2200658", "2707547", "2707549", "2707551", "2707553", "2707555", "2707557", "2736944", "2736946", "2736948"], "spl_set_id": ["27f15fac-7d98-4114-a2ec-92494a91da98"], "pharm_class_cs": ["Glucagon-Like Peptide 1 [CS]"], "pharm_class_epc": ["GLP-1 Receptor Agonist [EPC]"], "pharm_class_moa": ["Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, GLASS (0169-4303-30)", "package_ndc": "0169-4303-30", "marketing_start_date": "20211004"}, {"sample": true, "description": "30 TABLET in 1 BOTTLE, GLASS (0169-4303-99)", "package_ndc": "0169-4303-99", "marketing_start_date": "20211004"}], "brand_name": "RYBELSUS", "product_id": "0169-4303_dfe441cd-c20f-452b-a8a5-3a6017b6b006", "dosage_form": "TABLET", "pharm_class": ["GLP-1 Receptor Agonist [EPC]", "Glucagon-Like Peptide 1 [CS]", "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"], "product_ndc": "0169-4303", "generic_name": "oral semaglutide", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RYBELSUS", "active_ingredients": [{"name": "SEMAGLUTIDE", "strength": "3 mg/1"}], "application_number": "NDA213051", "marketing_category": "NDA", "marketing_start_date": "20190920", "listing_expiration_date": "20271231"}