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 INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

atropine sulfate 1 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-001
Product ID 84549-001_3ef1a1a0-93c2-e6b6-e063-6294a90aa2b6
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 84549001
Hyphenated Format 84549-001

Supplemental Identifiers

RxCUI
1190795
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 ANDA216120 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, GLASS (84549-001-25)
source: ndc

Packages (1)

84549-001-25 1 mL in 1 VIAL, GLASS (84549-001-25)

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": "3ef1a1a0-93c2-e6b6-e063-6294a90aa2b6", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190795"], "spl_set_id": ["3ef1a1a0-93c1-e6b6-e063-6294a90aa2b6"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, GLASS (84549-001-25)", "package_ndc": "84549-001-25", "marketing_start_date": "20250917"}], "brand_name": "Atropine Sulfate", "product_id": "84549-001_3ef1a1a0-93c2-e6b6-e063-6294a90aa2b6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "84549-001", "generic_name": "ATROPINE SULFATE", "labeler_name": "ProPharma Distribution", "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"}