atropine sulfate

Generic: atropine sulfate

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

Drug Facts

Product Profile

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

atropine sulfate .1 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1289
Product ID 51662-1289_1250f9a9-93b2-a4c1-e063-6394a90a7b36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021146
Listing Expiration 2026-12-31
Marketing Start 2018-09-23

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 516621289
Hyphenated Format 51662-1289

Supplemental Identifiers

RxCUI
1190546
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 NDA021146 (source: ndc)
Routes
ENDOTRACHEAL INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (51662-1289-1) / 10 mL in 1 SYRINGE, PLASTIC
  • 10 POUCH in 1 CASE (51662-1289-3) / 1 CARTON in 1 POUCH (51662-1289-2) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (2)

51662-1289-1 1 SYRINGE, PLASTIC in 1 CARTON (51662-1289-1) / 10 mL in 1 SYRINGE, PLASTIC 51662-1289-3 10 POUCH in 1 CASE (51662-1289-3) / 1 CARTON in 1 POUCH (51662-1289-2) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

atropine sulfate (.1 mg/mL)

Linked Drug Pages (1)

ATROPINE SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ENDOTRACHEAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "1250f9a9-93b2-a4c1-e063-6394a90a7b36", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190546"], "spl_set_id": ["768dc21a-b7d9-144c-e053-2991aa0af889"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (51662-1289-1)  / 10 mL in 1 SYRINGE, PLASTIC", "package_ndc": "51662-1289-1", "marketing_start_date": "20180923"}, {"sample": false, "description": "10 POUCH in 1 CASE (51662-1289-3)  / 1 CARTON in 1 POUCH (51662-1289-2)  / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC", "package_ndc": "51662-1289-3", "marketing_start_date": "20221212"}], "brand_name": "ATROPINE SULFATE", "product_id": "51662-1289_1250f9a9-93b2-a4c1-e063-6394a90a7b36", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "51662-1289", "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": ".1 mg/mL"}], "application_number": "NDA021146", "marketing_category": "NDA", "marketing_start_date": "20180923", "listing_expiration_date": "20261231"}