atropine sulfate

Generic: atropine sulfate

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-001
Product ID 82260-001_4a46793e-5e69-1a65-e063-6294a90a6880
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA213581
Listing Expiration 2027-12-31
Marketing Start 2023-04-21

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 82260001
Hyphenated Format 82260-001

Supplemental Identifiers

RxCUI
1190655
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 NDA213581 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIAL
source: ndc

Packages (1)

82260-001-01 10 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIAL

Ingredients (1)

atropine sulfate (10 mg/mL)

Linked Drug Pages (1)

Atropine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4a46793e-5e69-1a65-e063-6294a90a6880", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["e294ce2b-6bb5-4f84-8a6d-ce2402ed926d"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (82260-001-01)  / .4 mL in 1 VIAL", "package_ndc": "82260-001-01", "marketing_start_date": "20230421"}], "brand_name": "Atropine Sulfate", "product_id": "82260-001_4a46793e-5e69-1a65-e063-6294a90a6880", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "82260-001", "generic_name": "Atropine Sulfate", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "NDA213581", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230421", "listing_expiration_date": "20271231"}