ozempic

Generic: semaglutide

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

Drug Facts

Product Profile

Brand Name ozempic
Generic Name semaglutide
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

semaglutide 2.68 mg/mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-4772
Product ID 0169-4772_341dc8b9-9576-48a7-b8d8-c583c67b7007
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209637
Listing Expiration 2027-12-31
Marketing Start 2022-04-25

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 01694772
Hyphenated Format 0169-4772

Supplemental Identifiers

RxCUI
1991306 1991311 1991316 1991317 2398841 2398842 2599362 2599365 2619152 2619154
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 ozempic (source: ndc)
Generic Name semaglutide (source: ndc)
Application Number NDA209637 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.68 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-12) / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-11)
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-90)
source: ndc

Packages (2)

0169-4772-12 1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-12) / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-11) 0169-4772-97 1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-90)

Ingredients (1)

semaglutide (2.68 mg/mL)

Linked Drug Pages (1)

Ozempic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "341dc8b9-9576-48a7-b8d8-c583c67b7007", "openfda": {"nui": ["N0000178480", "M0160181", "N0000020058"], "unii": ["53AXN4NNHX"], "rxcui": ["1991306", "1991311", "1991316", "1991317", "2398841", "2398842", "2599362", "2599365", "2619152", "2619154"], "spl_set_id": ["adec4fd2-6858-4c99-91d4-531f5f2a2d79"], "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": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-12)  / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-11)", "package_ndc": "0169-4772-12", "marketing_start_date": "20220425"}, {"sample": true, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0169-4772-97)  / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-90)", "package_ndc": "0169-4772-97", "marketing_start_date": "20220425"}], "brand_name": "Ozempic", "product_id": "0169-4772_341dc8b9-9576-48a7-b8d8-c583c67b7007", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["GLP-1 Receptor Agonist [EPC]", "Glucagon-Like Peptide 1 [CS]", "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"], "product_ndc": "0169-4772", "generic_name": "semaglutide", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ozempic", "active_ingredients": [{"name": "SEMAGLUTIDE", "strength": "2.68 mg/mL"}], "application_number": "NDA209637", "marketing_category": "NDA", "marketing_start_date": "20220425", "listing_expiration_date": "20271231"}