FDA.reportPublic FDA data

OZEMPIC

Product NDC
0169-1704
11-digit product format
001691704
Labeler code
0169
Product ID
0169-1704_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
4 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

Additional Listing Data#

Finished product
Yes
Brand name base
OZEMPIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii53AXN4NNHX
Rxcui2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9dd2abc7-744f-456b-a273-dec083824bd8Product name220240229
487bac84-7c5b-40cf-afd2-8b9674d4648eProduct name120220118
21318a8d-e167-4f44-9627-3daede9532ffProduct name120200227

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-1704-30OZEMPIC30 in 1 BOTTLE, PLASTICTABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-1704-30EA - Each0169-170432bbe108-7923-4e57-96d1-07d0751ae3d312026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2736944OZEMPIC 1.5 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2736946OZEMPIC 4 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2736948OZEMPIC 9 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2707549RYBELSUS 1.5 MG Oral Tablet, Formulation R2PSN27f15fac-7d98-4114-a2ec-92494a91da9813
2200650RYBELSUS 14 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2200654RYBELSUS 3 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2707553RYBELSUS 4 MG Oral Tablet, Formulation R2PSN27f15fac-7d98-4114-a2ec-92494a91da9813
2200658RYBELSUS 7 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2707557RYBELSUS 9 MG Oral Tablet, Formulation R2PSN27f15fac-7d98-4114-a2ec-92494a91da9813
2707547semaglutide 1.5 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2200644semaglutide 14 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2200652semaglutide 3 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2707551semaglutide 4 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2200656semaglutide 7 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2707555semaglutide 9 MG Oral TabletPSN27f15fac-7d98-4114-a2ec-92494a91da9813
2736944semaglutide 1.5 MG Oral Tablet [Ozempic]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2707549semaglutide 1.5 MG Oral Tablet [Rybelsus]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2200650semaglutide 14 MG Oral Tablet [Rybelsus]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2200654semaglutide 3 MG Oral Tablet [Rybelsus]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2736946semaglutide 4 MG Oral Tablet [Ozempic]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2707553semaglutide 4 MG Oral Tablet [Rybelsus]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2200658semaglutide 7 MG Oral Tablet [Rybelsus]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2736948semaglutide 9 MG Oral Tablet [Ozempic]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2707557semaglutide 9 MG Oral Tablet [Rybelsus]SBD27f15fac-7d98-4114-a2ec-92494a91da9813
2707547semaglutide 1.5 MG Oral TabletSCD27f15fac-7d98-4114-a2ec-92494a91da9813
2200644semaglutide 14 MG Oral TabletSCD27f15fac-7d98-4114-a2ec-92494a91da9813
2200652semaglutide 3 MG Oral TabletSCD27f15fac-7d98-4114-a2ec-92494a91da9813
2707551semaglutide 4 MG Oral TabletSCD27f15fac-7d98-4114-a2ec-92494a91da9813
2200656semaglutide 7 MG Oral TabletSCD27f15fac-7d98-4114-a2ec-92494a91da9813
2707555semaglutide 9 MG Oral TabletSCD27f15fac-7d98-4114-a2ec-92494a91da9813
2736944Ozempic 1.5 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2736946Ozempic 4 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2736948Ozempic 9 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2707549Rybelsus 1.5 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2200650Rybelsus 14 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2200654Rybelsus 3 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2707553Rybelsus 4 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2200658Rybelsus 7 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813
2707557Rybelsus 9 MG Oral TabletSY27f15fac-7d98-4114-a2ec-92494a91da9813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0169-1704-300016917043030 TABLET in 1 BOTTLE, PLASTIC (0169-1704-30) 30 tablet2026-04-27NoNoCurrent