atropine

Generic: atropine sulfate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine
Generic Name atropine sulfate
Labeler amneal pharmaceuticals ny llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1748
Product ID 60219-1748_1b2b68ed-bad1-4742-b88d-1d2f0040ad52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214752
Listing Expiration 2026-12-31
Marketing Start 2022-07-19

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 602191748
Hyphenated Format 60219-1748

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 (source: ndc)
Generic Name atropine sulfate (source: ndc)
Application Number ANDA214752 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60219-1748-2) / 2 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

60219-1748-2 1 BOTTLE, DROPPER in 1 CARTON (60219-1748-2) / 2 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": "1b2b68ed-bad1-4742-b88d-1d2f0040ad52", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["f8718be5-8fa4-4c36-a4fd-fac7c3953f5a"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60219-1748-2)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "60219-1748-2", "marketing_start_date": "20220719"}], "brand_name": "Atropine", "product_id": "60219-1748_1b2b68ed-bad1-4742-b88d-1d2f0040ad52", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "60219-1748", "generic_name": "Atropine Sulfate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA214752", "marketing_category": "ANDA", "marketing_start_date": "20220719", "listing_expiration_date": "20261231"}