atropine sulfate

Generic: atropine sulfate

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

atropine sulfate 1 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-1001
Product ID 0517-1001_1c500ed9-94a9-472c-bfb7-50e1fcfc31fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216120
Listing Expiration 2026-12-31
Marketing Start 2022-08-02

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 05171001
Hyphenated Format 0517-1001

Supplemental Identifiers

RxCUI
1190795 1666781
UPC
0305171004254 0305171001253
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 ANDA216120 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 TRAY (0517-1001-25) / 1 mL in 1 VIAL, GLASS (0517-1001-01)
source: ndc

Packages (1)

0517-1001-25 25 VIAL, GLASS in 1 TRAY (0517-1001-25) / 1 mL in 1 VIAL, GLASS (0517-1001-01)

Ingredients (1)

atropine sulfate (1 mg/mL)

Linked Drug Pages (1)

Atropine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1c500ed9-94a9-472c-bfb7-50e1fcfc31fb", "openfda": {"upc": ["0305171004254", "0305171001253"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190795", "1666781"], "spl_set_id": ["6fee1727-52b7-4f73-ab45-ef47d6a1c5bb"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 TRAY (0517-1001-25)  / 1 mL in 1 VIAL, GLASS (0517-1001-01)", "package_ndc": "0517-1001-25", "marketing_start_date": "20220802"}], "brand_name": "Atropine Sulfate", "product_id": "0517-1001_1c500ed9-94a9-472c-bfb7-50e1fcfc31fb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0517-1001", "generic_name": "ATROPINE SULFATE", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA216120", "marketing_category": "ANDA", "marketing_start_date": "20220802", "listing_expiration_date": "20261231"}