atropine sulfate

Generic: atropine sulfate monohydrate

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

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate monohydrate
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 70069-716
Product ID 70069-716_07ece291-b401-4c28-9c81-6b686aa36e07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217791
Listing Expiration 2026-12-31
Marketing Start 2024-05-24

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 70069716
Hyphenated Format 70069-716

Supplemental Identifiers

RxCUI
1190655
UPC
0370069716014
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 monohydrate (source: ndc)
Application Number ANDA217791 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-716-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-716-01 1 BOTTLE in 1 CARTON (70069-716-01) / 5 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": "07ece291-b401-4c28-9c81-6b686aa36e07", "openfda": {"upc": ["0370069716014"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["bfdb85b2-86d0-4f32-a8fa-272af48a191c"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-716-01)  / 5 mL in 1 BOTTLE", "package_ndc": "70069-716-01", "marketing_start_date": "20240524"}], "brand_name": "Atropine Sulfate", "product_id": "70069-716_07ece291-b401-4c28-9c81-6b686aa36e07", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70069-716", "generic_name": "Atropine Sulfate Monohydrate", "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": "ANDA217791", "marketing_category": "ANDA", "marketing_start_date": "20240524", "listing_expiration_date": "20261231"}