atropine sulfate

Generic: atropine sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6251
Product ID 0641-6251_f5ca4281-8c89-4efc-80b1-2fbcf61c7c55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213561
Listing Expiration 2026-12-31
Marketing Start 2021-12-01

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 06416251
Hyphenated Format 0641-6251

Supplemental Identifiers

RxCUI
1190776
UPC
0306416251105
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 ANDA213561 (source: ndc)
Routes
ENDOTRACHEAL INTRAMEDULLARY INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0641-6251-10) / 20 mL in 1 VIAL
source: ndc

Packages (1)

0641-6251-10 10 VIAL in 1 CARTON (0641-6251-10) / 20 mL in 1 VIAL

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": "f5ca4281-8c89-4efc-80b1-2fbcf61c7c55", "openfda": {"upc": ["0306416251105"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190776"], "spl_set_id": ["4c15d3cc-7888-4c82-b3f8-a5d93c5523df"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6251-10)  / 20 mL in 1 VIAL", "package_ndc": "0641-6251-10", "marketing_start_date": "20211201"}], "brand_name": "Atropine Sulfate", "product_id": "0641-6251_f5ca4281-8c89-4efc-80b1-2fbcf61c7c55", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0641-6251", "generic_name": "Atropine Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".4 mg/mL"}], "application_number": "ANDA213561", "marketing_category": "ANDA", "marketing_start_date": "20211201", "listing_expiration_date": "20261231"}