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
INTRAVENOUS
Active Ingredients

atropine sulfate 1 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9989
Product ID 0404-9989_edaf1d42-c2af-4369-8d75-b3a93d70d390
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214652
Listing Expiration 2026-12-31
Marketing Start 2023-09-05

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 04049989
Hyphenated Format 0404-9989

Supplemental Identifiers

RxCUI
1190795
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 NDA214652 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9989-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9989-01 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9989-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

atropine sulfate (1 mg/mL)

Linked Drug Pages (1)

Atropine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "edaf1d42-c2af-4369-8d75-b3a93d70d390", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190795"], "spl_set_id": ["4a9559e8-7a34-4509-a8cc-ff0125694539"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9989-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9989-01", "marketing_start_date": "20230912"}], "brand_name": "Atropine Sulfate", "product_id": "0404-9989_edaf1d42-c2af-4369-8d75-b3a93d70d390", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0404-9989", "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": "1 mg/mL"}], "application_number": "NDA214652", "marketing_category": "NDA", "marketing_start_date": "20230905", "listing_expiration_date": "20261231"}