atropine

Generic: atropine sulfate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine
Generic Name atropine sulfate
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6226
Product ID 60505-6226_b7f34028-c9e4-4505-1395-1e65fd56e27f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215624
Listing Expiration 2027-12-31
Marketing Start 2021-11-26

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 605056226
Hyphenated Format 60505-6226

Supplemental Identifiers

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 (source: ndc)
Generic Name atropine sulfate (source: ndc)
Application Number ANDA215624 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0) / 2 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-1) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-2) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

60505-6226-0 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0) / 2 mL in 1 BOTTLE, DROPPER 60505-6226-1 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-1) / 5 mL in 1 BOTTLE, DROPPER 60505-6226-2 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-2) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

atropine sulfate (10 mg/mL)

Linked Drug Pages (1)

Atropine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b7f34028-c9e4-4505-1395-1e65fd56e27f", "openfda": {"unii": ["03J5ZE7KA5"], "spl_set_id": ["127a7e32-a150-01d6-a66a-b7708d85809f"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-6226-0", "marketing_start_date": "20211126"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-6226-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-6226-1", "marketing_start_date": "20211126"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-6226-2)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-6226-2", "marketing_start_date": "20220207"}], "brand_name": "Atropine", "product_id": "60505-6226_b7f34028-c9e4-4505-1395-1e65fd56e27f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "60505-6226", "generic_name": "Atropine Sulfate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA215624", "marketing_category": "ANDA", "marketing_start_date": "20211126", "listing_expiration_date": "20271231"}