atropine sulfate

Generic: atropine sulfate

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler alcon laboratories, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0817
Product ID 0065-0817_7dfe4742-7045-491c-912e-e4e83bc13720
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208151
Listing Expiration 2026-12-31
Marketing Start 2022-11-01

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 00650817
Hyphenated Format 0065-0817

Supplemental Identifiers

RxCUI
1190655
UPC
0300650817011 0300650817028
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 NDA208151 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02) / 2 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

0065-0817-01 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPER 0065-0817-02 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02) / 2 mL in 1 BOTTLE, DROPPER

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": "7dfe4742-7045-491c-912e-e4e83bc13720", "openfda": {"upc": ["0300650817011", "0300650817028"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["c8093125-ed1a-4eb6-9c81-52c5c7376481"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-0817-01", "marketing_start_date": "20221101"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-0817-02", "marketing_start_date": "20221101"}], "brand_name": "atropine sulfate", "product_id": "0065-0817_7dfe4742-7045-491c-912e-e4e83bc13720", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0065-0817", "generic_name": "atropine sulfate", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atropine sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "NDA208151", "marketing_category": "NDA", "marketing_start_date": "20221101", "listing_expiration_date": "20261231"}