atropine sulfate

Generic: atropine sulfate

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler redpharm drug
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

atropine sulfate 10 mg/mL

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2124
Product ID 67296-2124_4698b40d-9962-2dee-e063-6294a90a4287
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218148
Listing Expiration 2026-12-31
Marketing Start 2024-01-08

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 672962124
Hyphenated Format 67296-2124

Supplemental Identifiers

RxCUI
1190655
UPC
0370756653356 0370756652250
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 ANDA218148 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (67296-2124-5) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

67296-2124-5 1 BOTTLE in 1 CARTON (67296-2124-5) / 5 mL in 1 BOTTLE

Ingredients (1)

atropine sulfate (10 mg/mL)

Linked Drug Pages (1)

Atropine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4698b40d-9962-2dee-e063-6294a90a4287", "openfda": {"upc": ["0370756653356", "0370756652250"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190655"], "spl_set_id": ["301ea0f4-a1dc-ad4f-e063-6294a90acc1c"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (67296-2124-5)  / 5 mL in 1 BOTTLE", "package_ndc": "67296-2124-5", "marketing_start_date": "20240108"}], "brand_name": "Atropine Sulfate", "product_id": "67296-2124_4698b40d-9962-2dee-e063-6294a90a4287", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "67296-2124", "generic_name": "Atropine Sulfate", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA218148", "marketing_category": "ANDA", "marketing_start_date": "20240108", "listing_expiration_date": "20261231"}