atropine sulfate

Generic: atropine sulfate

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-580
Product ID 84549-580_463c2db1-15a5-da49-e063-6394a90a74bf
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 84549580
Hyphenated Format 84549-580

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
  • 20 mL in 1 VIAL, MULTI-DOSE (84549-580-20)
source: ndc

Packages (1)

84549-580-20 20 mL in 1 VIAL, MULTI-DOSE (84549-580-20)

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": "463c2db1-15a5-da49-e063-6394a90a74bf", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190776"], "spl_set_id": ["38404931-980b-0019-e063-6394a90a933f"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL, MULTI-DOSE (84549-580-20)", "package_ndc": "84549-580-20", "marketing_start_date": "20250827"}], "brand_name": "Atropine Sulfate", "product_id": "84549-580_463c2db1-15a5-da49-e063-6394a90a74bf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "84549-580", "generic_name": "Atropine Sulfate", "labeler_name": "ProPharma Distribution", "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"}