OZEMPIC

Product NDC
0169-1709
11-digit product format
001691709
Labeler code
0169
Product ID
0169-1709_5176eed4-f8f8-4f88-a079-11f16864f40a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oral semaglutide
Dosage form
TABLET
Route
ORAL
Labeler
Novo Nordisk Pharmaceutical Industries, LP
Application
NDA213051
Marketing category
NDA
Marketing start
2026-04-27
Substance
SEMAGLUTIDE
Active strength
9 mg/1
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
53AXN4NNHXSEMAGLUTIDE910463-68-2SEMAGLUTIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0169-1709-300016917093030 TABLET in 1 BOTTLE, PLASTIC (0169-1709-30) 30 tablet2026-04-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OZEMPICNovo Nordisk Pharmaceutical Industries, LP2026-01-30HUMAN PRESCRIPTION DRUG LABEL13
RYBELSUSNovo Nordisk2024-12-09HUMAN PRESCRIPTION DRUG LABEL10