atropine sulfate

Generic: atropine sulfate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

atropine sulfate .4 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4188
Product ID 70518-4188_3ff282ac-a0db-a6e8-e063-6394a90ac8b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209260
Listing Expiration 2026-12-31
Marketing Start 2024-09-26

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 705184188
Hyphenated Format 70518-4188

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
  • 10 VIAL, MULTI-DOSE in 1 TRAY (70518-4188-0) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4188-1)
source: ndc

Packages (1)

70518-4188-0 10 VIAL, MULTI-DOSE in 1 TRAY (70518-4188-0) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4188-1)

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": "3ff282ac-a0db-a6e8-e063-6394a90ac8b0", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190776"], "spl_set_id": ["532aa441-92ec-42d6-862a-639f8cfe9951"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 TRAY (70518-4188-0)  / 20 mL in 1 VIAL, MULTI-DOSE (70518-4188-1)", "package_ndc": "70518-4188-0", "marketing_start_date": "20240926"}], "brand_name": "Atropine Sulfate", "product_id": "70518-4188_3ff282ac-a0db-a6e8-e063-6394a90ac8b0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70518-4188", "generic_name": "Atropine Sulfate", "labeler_name": "REMEDYREPACK 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": "20240926", "listing_expiration_date": "20261231"}