atropine sulfate

Generic: atropine sulfate

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler propharma distribution
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-631
Product ID 84549-631_3eef6300-9c77-82b2-e063-6294a90a5499
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215969
Listing Expiration 2026-12-31
Marketing Start 2024-07-04

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 84549631
Hyphenated Format 84549-631

Supplemental Identifiers

RxCUI
1666781
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 sulfate (source: ndc)
Generic Name atropine sulfate (source: ndc)
Application Number ANDA215969 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL (84549-631-25)
source: ndc

Packages (1)

84549-631-25 1 mL in 1 VIAL (84549-631-25)

Ingredients (1)

atropine sulfate (.4 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": "3eef6300-9c77-82b2-e063-6294a90a5499", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1666781"], "spl_set_id": ["3eef6300-9c78-82b2-e063-6294a90a5499"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL (84549-631-25)", "package_ndc": "84549-631-25", "marketing_start_date": "20250916"}], "brand_name": "Atropine Sulfate", "product_id": "84549-631_3eef6300-9c77-82b2-e063-6294a90a5499", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "84549-631", "generic_name": "Atropine Sulfate", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".4 mg/mL"}], "application_number": "ANDA215969", "marketing_category": "ANDA", "marketing_start_date": "20240704", "listing_expiration_date": "20261231"}