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
INTRAVASCULAR
Active Ingredients

atropine sulfate .4 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6274
Product ID 0641-6274_4298dd9c-15f7-4bab-be40-c0250eb01886
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217345
Listing Expiration 2027-12-31
Marketing Start 2025-11-07

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 06416274
Hyphenated Format 0641-6274

Supplemental Identifiers

RxCUI
1190795 1666781
UPC
0306416275255
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 ANDA217345 (source: ndc)
Routes
INTRAVASCULAR
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6274-25) / 1 mL in 1 VIAL (0641-6274-01)
source: ndc

Packages (1)

0641-6274-25 25 VIAL in 1 CARTON (0641-6274-25) / 1 mL in 1 VIAL (0641-6274-01)

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": ["INTRAVASCULAR"], "spl_id": "4298dd9c-15f7-4bab-be40-c0250eb01886", "openfda": {"upc": ["0306416275255"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190795", "1666781"], "spl_set_id": ["a66eecf9-2d8b-4e2d-8a05-d718dcbc3542"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6274-25)  / 1 mL in 1 VIAL (0641-6274-01)", "package_ndc": "0641-6274-25", "marketing_start_date": "20251107"}], "brand_name": "Atropine Sulfate", "product_id": "0641-6274_4298dd9c-15f7-4bab-be40-c0250eb01886", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0641-6274", "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": "ANDA217345", "marketing_category": "ANDA", "marketing_start_date": "20251107", "listing_expiration_date": "20271231"}