atropine sulfate

Generic: atropine sulfate

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler accord healthcare inc.
Dosage Form INJECTION, SOLUTION
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-512
Product ID 16729-512_275def6c-5b2d-918b-e063-6294a90aa71f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213424
Listing Expiration 2026-12-31
Marketing Start 2021-03-25

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 16729512
Hyphenated Format 16729-512

Supplemental Identifiers

RxCUI
1190776
UPC
0316729512053
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 ANDA213424 (source: ndc)
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 BOX (16729-512-43) / 1 VIAL, MULTI-DOSE in 1 CARTON (16729-512-05) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

16729-512-43 10 CARTON in 1 BOX (16729-512-43) / 1 VIAL, MULTI-DOSE in 1 CARTON (16729-512-05) / 20 mL in 1 VIAL, MULTI-DOSE

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": ["ENDOTRACHEAL", "INTRAMEDULLARY", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "275def6c-5b2d-918b-e063-6294a90aa71f", "openfda": {"upc": ["0316729512053"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190776"], "spl_set_id": ["f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c7"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 BOX (16729-512-43)  / 1 VIAL, MULTI-DOSE in 1 CARTON (16729-512-05)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-512-43", "marketing_start_date": "20210325"}], "brand_name": "Atropine Sulfate", "product_id": "16729-512_275def6c-5b2d-918b-e063-6294a90aa71f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16729-512", "generic_name": "Atropine Sulfate", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".4 mg/mL"}], "application_number": "ANDA213424", "marketing_category": "ANDA", "marketing_start_date": "20210325", "listing_expiration_date": "20261231"}