atropine sulfate

Generic: atropine sulfate injection

Labeler: medefil, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate injection
Labeler medefil, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

atropine sulfate .1 mg/mL

Manufacturer
Medefil, Inc.

Identifiers & Regulatory

Product NDC 64253-400
Product ID 64253-400_46a6a31f-46ab-a437-e063-6394a90a4ad0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214970
Listing Expiration 2026-12-31
Marketing Start 2023-05-11

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 64253400
Hyphenated Format 64253-400

Supplemental Identifiers

RxCUI
1190546
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 injection (source: ndc)
Application Number ANDA214970 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 SYRINGE, PLASTIC in 1 BOX (64253-400-91) / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30)
source: ndc

Packages (1)

64253-400-91 10 SYRINGE, PLASTIC in 1 BOX (64253-400-91) / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30)

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": ["INTRAVENOUS"], "spl_id": "46a6a31f-46ab-a437-e063-6394a90a4ad0", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190546"], "spl_set_id": ["fbfdf718-befe-ad22-e053-6294a90a3715"], "manufacturer_name": ["Medefil, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE, PLASTIC in 1 BOX (64253-400-91)  / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30)", "package_ndc": "64253-400-91", "marketing_start_date": "20230511"}], "brand_name": "Atropine Sulfate", "product_id": "64253-400_46a6a31f-46ab-a437-e063-6394a90a4ad0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "64253-400", "generic_name": "Atropine Sulfate Injection", "labeler_name": "Medefil, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".1 mg/mL"}], "application_number": "ANDA214970", "marketing_category": "ANDA", "marketing_start_date": "20230511", "listing_expiration_date": "20261231"}