atropine sulfate

Generic: atropine sulfate

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler henry schein, inc.
Dosage Form INJECTION, SOLUTION
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9804
Product ID 0404-9804_f146f48d-bd05-46f2-ad39-b930a05ea158
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209260
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa] cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049804
Hyphenated Format 0404-9804

Supplemental Identifiers

RxCUI
1190776
UNII
03J5ZE7KA5

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 atropine sulfate (source: ndc)
Generic Name atropine sulfate (source: ndc)
Application Number NDA209260 (source: ndc)
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BAG (0404-9804-20) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0404-9804-20 1 VIAL, MULTI-DOSE in 1 BAG (0404-9804-20) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

atropine sulfate (.4 mg/mL)

Linked Drug Pages (1)

Atropine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ENDOTRACHEAL", "INTRAMEDULLARY", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "f146f48d-bd05-46f2-ad39-b930a05ea158", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190776"], "spl_set_id": ["6acb3f07-9e32-4ad0-8336-e2f33d55b127"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9804-20)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9804-20", "marketing_start_date": "20241001"}], "brand_name": "Atropine Sulfate", "product_id": "0404-9804_f146f48d-bd05-46f2-ad39-b930a05ea158", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0404-9804", "generic_name": "Atropine Sulfate", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".4 mg/mL"}], "application_number": "NDA209260", "marketing_category": "NDA", "marketing_start_date": "20241001", "listing_expiration_date": "20261231"}