NDC 70518-2143

Ozempic

Semaglutide

Ozempic is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Semaglutide.

• Product ID: 70518-2143_8b9ed314-8801-961d-e053-2a95a90a3962
• NDC: 70518-2143
• Product Type: Human Prescription Drug
• Proprietary Name: Ozempic
• Generic Name: Semaglutide
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-06-11
• Marketing Category: NDA / NDA
• Application Number: NDA209637
• Labeler Name: REMEDYREPACK INC.
• Substance Name: SEMAGLUTIDE
• Active Ingredient Strength: 1 mg/mL
• 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 70518-2143-0

2 SYRINGE, PLASTIC in 1 CARTON (70518-2143-0) > 1.5 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2019-06-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2143-0 [70518214300]

Ozempic INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209637
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-11

Drug Details

Active Ingredients

Ingredient	Strength
SEMAGLUTIDE	1.34 mg/mL

OpenFDA Data

• SPL SET ID: b5399d16-01c1-4315-af3c-7619fee86621
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 53AXN4NNHX
• RxNorm Concept Unique ID - RxCUI:
  • 1991311
  • 1991306

Pharmacological Class

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

NDC Crossover Matching brand name "Ozempic" or generic name "Semaglutide"

NDC	Brand Name	Generic Name
0169-4130	Ozempic	semaglutide
0169-4132	Ozempic	semaglutide
0169-4136	Ozempic	semaglutide
0169-4181	Ozempic	semaglutide
0169-4772	Ozempic	semaglutide
50090-5138	Ozempic	semaglutide
50090-5139	Ozempic	semaglutide
70518-2143	Ozempic	Ozempic
0169-4501	WEGOVY	semaglutide
0169-4505	WEGOVY	semaglutide
0169-4517	WEGOVY	semaglutide
0169-4524	WEGOVY	semaglutide
0169-4525	WEGOVY	semaglutide