atropine sulfate

Generic: atropine sulfate

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler international medication systems, limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

atropine sulfate .1 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-3340
Product ID 76329-3340_697aa53c-f31f-463a-a752-d2faaad354db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212461
Listing Expiration 2026-12-31
Marketing Start 2021-02-17

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 763293340
Hyphenated Format 76329-3340

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 (source: ndc)
Application Number ANDA212461 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 PACKAGE (76329-3340-1) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE
source: ndc

Packages (1)

76329-3340-1 10 CARTON in 1 PACKAGE (76329-3340-1) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE

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": "697aa53c-f31f-463a-a752-d2faaad354db", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190546"], "spl_set_id": ["b72d0a82-6163-460f-965a-12f6da47370a"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 PACKAGE (76329-3340-1)  / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE", "package_ndc": "76329-3340-1", "marketing_start_date": "20210217"}], "brand_name": "Atropine Sulfate", "product_id": "76329-3340_697aa53c-f31f-463a-a752-d2faaad354db", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "76329-3340", "generic_name": "Atropine Sulfate", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".1 mg/mL"}], "application_number": "ANDA212461", "marketing_category": "ANDA", "marketing_start_date": "20210217", "listing_expiration_date": "20261231"}