atropine sulfate

Generic: atropine sulfate

Labeler: henry schein, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 .4 mg/mL

Manufacturer
Henry Schein, Inc

Identifiers & Regulatory

Product NDC 0404-9802
Product ID 0404-9802_14aff019-a9fe-486a-945e-5803bbd06841
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216120
Listing Expiration 2026-12-31
Marketing Start 2024-08-22

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 04049802
Hyphenated Format 0404-9802

Supplemental Identifiers

RxCUI
1666781
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 ANDA216120 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 BAG (0404-9802-01) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0404-9802-01 1 VIAL, GLASS in 1 BAG (0404-9802-01) / 1 mL in 1 VIAL, GLASS

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": ["INTRAVENOUS"], "spl_id": "14aff019-a9fe-486a-945e-5803bbd06841", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1666781"], "spl_set_id": ["b753894e-81f8-4e81-b07a-c338311ded5b"], "manufacturer_name": ["Henry Schein, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 BAG (0404-9802-01)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "0404-9802-01", "marketing_start_date": "20240822"}], "brand_name": "Atropine Sulfate", "product_id": "0404-9802_14aff019-a9fe-486a-945e-5803bbd06841", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0404-9802", "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": "ANDA216120", "marketing_category": "ANDA", "marketing_start_date": "20240822", "listing_expiration_date": "20261231"}