atropine sulfate

Generic: atropine sulfate

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1619
Product ID 51662-1619_100d196c-c853-3cf7-e063-6294a90ad8c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213561
Listing Expiration 2026-12-31
Marketing Start 2022-10-01

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 516621619
Hyphenated Format 51662-1619

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 ANDA213561 (source: ndc)
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 20 mL in 1 VIAL (51662-1619-1)
  • 10 POUCH in 1 CASE (51662-1619-3) / 1 VIAL in 1 POUCH (51662-1619-2) / 20 mL in 1 VIAL
source: ndc

Packages (2)

51662-1619-1 20 mL in 1 VIAL (51662-1619-1) 51662-1619-3 10 POUCH in 1 CASE (51662-1619-3) / 1 VIAL in 1 POUCH (51662-1619-2) / 20 mL in 1 VIAL

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": "100d196c-c853-3cf7-e063-6294a90ad8c2", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190776"], "spl_set_id": ["e9fd624a-9abd-dfea-e053-2a95a90a8e9d"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL (51662-1619-1)", "package_ndc": "51662-1619-1", "marketing_start_date": "20221110"}, {"sample": false, "description": "10 POUCH in 1 CASE (51662-1619-3)  / 1 VIAL in 1 POUCH (51662-1619-2)  / 20 mL in 1 VIAL", "package_ndc": "51662-1619-3", "marketing_start_date": "20221001"}], "brand_name": "ATROPINE SULFATE", "product_id": "51662-1619_100d196c-c853-3cf7-e063-6294a90ad8c2", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "51662-1619", "generic_name": "ATROPINE SULFATE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATROPINE SULFATE", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".4 mg/mL"}], "application_number": "ANDA213561", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20261231"}