atropine

Generic: atropine sulfate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine
Generic Name atropine sulfate
Labeler a-s medication solutions
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7313
Product ID 50090-7313_db93edb4-792e-4925-9002-90978afa8cb1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214752
Listing Expiration 2027-12-31
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 500907313
Hyphenated Format 50090-7313

Supplemental Identifiers

RxCUI
1190655
UNII
03J5ZE7KA5

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 (50090-7313-0) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50090-7313-0 1 BOTTLE, DROPPER in 1 CARTON (50090-7313-0) / 5 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": "db93edb4-792e-4925-9002-90978afa8cb1", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["b4736dbc-b7c8-4b33-b7a8-a47c5654a127"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-7313-0)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-7313-0", "marketing_start_date": "20241014"}], "brand_name": "ATROPINE", "product_id": "50090-7313_db93edb4-792e-4925-9002-90978afa8cb1", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "50090-7313", "generic_name": "atropine sulfate", "labeler_name": "A-S Medication Solutions", "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": "20271231"}