NDC 0169-4314

RYBELSUS

Oral Semaglutide

RYBELSUS is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Semaglutide.

• Product ID: 0169-4314_27f15fac-7d98-4114-a2ec-92494a91da98
• NDC: 0169-4314
• Product Type: Human Prescription Drug
• Proprietary Name: RYBELSUS
• Generic Name: Oral Semaglutide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-09-20
• Marketing Category: NDA / NDA
• Application Number: NDA213051
• Labeler Name: Novo Nordisk
• Substance Name: SEMAGLUTIDE
• Active Ingredient Strength: 14 mg/1
• Pharm Classes: GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0169-4314-13

3 BLISTER PACK in 1 CARTON (0169-4314-13) > 10 TABLET in 1 BLISTER PACK (0169-4314-01)

• Marketing Start Date: 2019-09-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0169-4314-13 [00169431413]

RYBELSUS TABLET

• Marketing Category: NDA
• Application Number: NDA213051
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-09-20

NDC 0169-4314-01 [00169431401]

RYBELSUS TABLET

• Marketing Category: NDA
• Application Number: NDA213051
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-20

Drug Details

Active Ingredients

Ingredient	Strength
SEMAGLUTIDE	14 mg/1

OpenFDA Data

• SPL SET ID: 27f15fac-7d98-4114-a2ec-92494a91da98
• Manufacturer:
  • Novo Nordisk
• UNII:
  • 53AXN4NNHX
• RxNorm Concept Unique ID - RxCUI:
  • 2200656
  • 2200654
  • 2200652
  • 2200650
  • 2200658
  • 2200644

Pharmacological Class

• GLP-1 Receptor Agonist [EPC]
• Glucagon-Like Peptide 1 [CS]
• Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

NDC Crossover Matching brand name "RYBELSUS" or generic name "Oral Semaglutide"

NDC	Brand Name	Generic Name
0169-4303	RYBELSUS	Oral Semaglutide
0169-4307	RYBELSUS	Oral Semaglutide
0169-4314	RYBELSUS	Oral Semaglutide