atropine sulfate

Generic: atropine sulfate

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

atropine sulfate 10 mg/mL

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-965
Product ID 24208-965_32c411c4-f4b0-fc14-e063-6394a90a2955
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213581
Listing Expiration 2026-12-31
Marketing Start 2022-07-13

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 24208965
Hyphenated Format 24208-965

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 (24208-965-01) / .4 mL in 1 VIAL
source: ndc

Packages (1)

Ingredients (1)

atropine sulfate (10 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "32c411c4-f4b0-fc14-e063-6394a90a2955", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["aeab333c-3cdb-45c0-9e22-949624d69fbc"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (24208-965-01)  / .4 mL in 1 VIAL", "package_ndc": "24208-965-01", "marketing_start_date": "20220713"}], "brand_name": "Atropine Sulfate", "product_id": "24208-965_32c411c4-f4b0-fc14-e063-6394a90a2955", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "24208-965", "generic_name": "Atropine Sulfate", "labeler_name": "Bausch & Lomb Incorporated", "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", "marketing_start_date": "20220713", "listing_expiration_date": "20261231"}