atropine sulfate

Generic: atropine sulfate

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler northstar rxllc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-264
Product ID 72603-264_06c8d08d-9c13-4e79-a369-d5019b1795c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218148
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

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 72603264
Hyphenated Format 72603-264

Supplemental Identifiers

RxCUI
1190655
UPC
0372603264029 0372603264012
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 ANDA218148 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72603-264-01) / 2 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72603-264-02) / 5 mL in 1 BOTTLE
source: ndc

Packages (2)

72603-264-01 1 BOTTLE in 1 CARTON (72603-264-01) / 2 mL in 1 BOTTLE 72603-264-02 1 BOTTLE in 1 CARTON (72603-264-02) / 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": "06c8d08d-9c13-4e79-a369-d5019b1795c6", "openfda": {"upc": ["0372603264029", "0372603264012"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["f750135c-e6bf-4aa7-a343-87b1204df94f"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72603-264-01)  / 2 mL in 1 BOTTLE", "package_ndc": "72603-264-01", "marketing_start_date": "20240901"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72603-264-02)  / 5 mL in 1 BOTTLE", "package_ndc": "72603-264-02", "marketing_start_date": "20240901"}], "brand_name": "Atropine Sulfate", "product_id": "72603-264_06c8d08d-9c13-4e79-a369-d5019b1795c6", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "72603-264", "generic_name": "Atropine Sulfate", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA218148", "marketing_category": "ANDA", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}