atropine sulfate

Generic: atropine sulfate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atropine sulfate
Generic Name atropine sulfate
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

atropine sulfate .1 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1706
Product ID 70121-1706_cd6e7dcc-16d0-4663-859e-c22fe300a536
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215342
Listing Expiration 2026-12-31
Marketing Start 2024-01-09

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 701211706
Hyphenated Format 70121-1706

Supplemental Identifiers

RxCUI
1190546 1190552
UPC
0370121170617
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 ANDA215342 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 TRAY in 1 CARTON (70121-1706-2) / 5 SYRINGE, GLASS in 1 TRAY / 10 mL in 1 SYRINGE, GLASS
  • 24 CARTON in 1 PACKAGE (70121-1706-4) / 1 SYRINGE, GLASS in 1 CARTON (70121-1706-1) / 10 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

70121-1706-2 10 TRAY in 1 CARTON (70121-1706-2) / 5 SYRINGE, GLASS in 1 TRAY / 10 mL in 1 SYRINGE, GLASS 70121-1706-4 24 CARTON in 1 PACKAGE (70121-1706-4) / 1 SYRINGE, GLASS in 1 CARTON (70121-1706-1) / 10 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": "cd6e7dcc-16d0-4663-859e-c22fe300a536", "openfda": {"upc": ["0370121170617"], "unii": ["03J5ZE7KA5"], "rxcui": ["1190546", "1190552"], "spl_set_id": ["80a31286-a741-4440-b200-290c08925d06"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CARTON (70121-1706-2)  / 5 SYRINGE, GLASS in 1 TRAY / 10 mL in 1 SYRINGE, GLASS", "package_ndc": "70121-1706-2", "marketing_start_date": "20240109"}, {"sample": false, "description": "24 CARTON in 1 PACKAGE (70121-1706-4)  / 1 SYRINGE, GLASS in 1 CARTON (70121-1706-1)  / 10 mL in 1 SYRINGE, GLASS", "package_ndc": "70121-1706-4", "marketing_start_date": "20240918"}], "brand_name": "atropine sulfate", "product_id": "70121-1706_cd6e7dcc-16d0-4663-859e-c22fe300a536", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70121-1706", "generic_name": "atropine sulfate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atropine sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".1 mg/mL"}], "application_number": "ANDA215342", "marketing_category": "ANDA", "marketing_start_date": "20240109", "listing_expiration_date": "20261231"}