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
Routes
INTRAVENOUS
Active Ingredients

atropine sulfate .1 mg/mL

Manufacturer
Accord Healthcare, Inc.,

Identifiers & Regulatory

Product NDC 16729-484
Product ID 16729-484_4082a1cf-1e1b-6f40-e063-6294a90aec06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212868
Listing Expiration 2026-12-31
Marketing Start 2021-07-30

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 16729484
Hyphenated Format 16729-484

Supplemental Identifiers

RxCUI
1190546 1190551 1190552
UPC
0316729483315 0316729484039 0316729484312
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 ANDA212868 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 mL in 1 SYRINGE, GLASS (16729-484-03)
  • 5 mL in 1 SYRINGE, GLASS (16729-484-31)
  • 10 SYRINGE, GLASS in 1 CARTON (16729-484-45) / 10 mL in 1 SYRINGE, GLASS
  • 10 SYRINGE, GLASS in 1 CARTON (16729-484-90) / 5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (4)

16729-484-03 10 mL in 1 SYRINGE, GLASS (16729-484-03) 16729-484-31 5 mL in 1 SYRINGE, GLASS (16729-484-31) 16729-484-45 10 SYRINGE, GLASS in 1 CARTON (16729-484-45) / 10 mL in 1 SYRINGE, GLASS 16729-484-90 10 SYRINGE, GLASS in 1 CARTON (16729-484-90) / 5 mL in 1 SYRINGE, GLASS

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": "4082a1cf-1e1b-6f40-e063-6294a90aec06", "openfda": {"upc": ["0316729483315", "0316729484039", "0316729484312"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190546", "1190551", "1190552"], "spl_set_id": ["c82cb295-ffce-47d6-97ad-a8aa723f4e4f"], "manufacturer_name": ["Accord Healthcare, Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 SYRINGE, GLASS (16729-484-03)", "package_ndc": "16729-484-03", "marketing_start_date": "20210730"}, {"sample": false, "description": "5 mL in 1 SYRINGE, GLASS (16729-484-31)", "package_ndc": "16729-484-31", "marketing_start_date": "20210730"}, {"sample": false, "description": "10 SYRINGE, GLASS in 1 CARTON (16729-484-45)  / 10 mL in 1 SYRINGE, GLASS", "package_ndc": "16729-484-45", "marketing_start_date": "20210819"}, {"sample": false, "description": "10 SYRINGE, GLASS in 1 CARTON (16729-484-90)  / 5 mL in 1 SYRINGE, GLASS", "package_ndc": "16729-484-90", "marketing_start_date": "20210819"}], "brand_name": "ATROPINE SULFATE", "product_id": "16729-484_4082a1cf-1e1b-6f40-e063-6294a90aec06", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16729-484", "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": ".1 mg/mL"}], "application_number": "ANDA212868", "marketing_category": "ANDA", "marketing_start_date": "20210730", "listing_expiration_date": "20261231"}