atropine sulfate

Generic: atropine sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-580
Product ID 63323-580_8039a2a4-4c0a-4062-9ca5-78137ba74082
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209260
Listing Expiration 2026-12-31
Marketing Start 2017-01-23

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 63323580
Hyphenated Format 63323-580

Supplemental Identifiers

RxCUI
1190776
UNII
03J5ZE7KA5

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 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
  • 10 VIAL, MULTI-DOSE in 1 TRAY (63323-580-20) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

63323-580-20 10 VIAL, MULTI-DOSE in 1 TRAY (63323-580-20) / 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": "8039a2a4-4c0a-4062-9ca5-78137ba74082", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190776"], "spl_set_id": ["310c8a74-ea24-4357-8099-81e394b1634e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 TRAY (63323-580-20)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-580-20", "marketing_start_date": "20170123"}], "brand_name": "Atropine Sulfate", "product_id": "63323-580_8039a2a4-4c0a-4062-9ca5-78137ba74082", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "63323-580", "generic_name": "Atropine Sulfate", "labeler_name": "Fresenius Kabi USA, LLC", "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": "20170123", "listing_expiration_date": "20261231"}