atropine sulfate

Generic: atropine sulfate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-583
Product ID 70069-583_43d3dd59-36b1-493f-86a3-c5eee9750ee8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215618
Listing Expiration 2026-12-31
Marketing Start 2025-02-12

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 70069583
Hyphenated Format 70069-583

Supplemental Identifiers

RxCUI
1190655
UPC
0370069582015 0370069583012 0370069581018
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 ANDA215618 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-583-01) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-583-01 1 BOTTLE in 1 CARTON (70069-583-01) / 15 mL in 1 BOTTLE

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": "43d3dd59-36b1-493f-86a3-c5eee9750ee8", "openfda": {"upc": ["0370069582015", "0370069583012", "0370069581018"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["e30491ed-938e-4ef4-aa23-a2e94cbab0ed"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-583-01)  / 15 mL in 1 BOTTLE", "package_ndc": "70069-583-01", "marketing_start_date": "20250212"}], "brand_name": "Atropine sulfate", "product_id": "70069-583_43d3dd59-36b1-493f-86a3-c5eee9750ee8", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70069-583", "generic_name": "Atropine sulfate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA215618", "marketing_category": "ANDA", "marketing_start_date": "20250212", "listing_expiration_date": "20261231"}