neostigmine methylsulfate

Generic: neostigmine methylsulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name neostigmine methylsulfate
Generic Name neostigmine methylsulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

neostigmine methylsulfate 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-415
Product ID 63323-415_3abc0611-0e8c-49f9-9678-e4b2fda3d8ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203629
Listing Expiration 2026-12-31
Marketing Start 2015-01-08

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323415
Hyphenated Format 63323-415

Supplemental Identifiers

RxCUI
311935 311936
UPC
0363323415013 0363323413019
UNII
98IMH7M386

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 neostigmine methylsulfate (source: ndc)
Generic Name neostigmine methylsulfate (source: ndc)
Application Number NDA203629 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 TRAY (63323-415-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-415-01)
source: ndc

Packages (1)

63323-415-10 10 VIAL, MULTI-DOSE in 1 TRAY (63323-415-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-415-01)

Ingredients (1)

neostigmine methylsulfate (1 mg/mL)

Linked Drug Pages (2)

Neostigmine Methylsulfate ndc-match (0.9) Neostigmine Methylsulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3abc0611-0e8c-49f9-9678-e4b2fda3d8ed", "openfda": {"upc": ["0363323415013", "0363323413019"], "unii": ["98IMH7M386"], "rxcui": ["311935", "311936"], "spl_set_id": ["6448229c-e650-47ba-bb00-cba3604502c5"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 TRAY (63323-415-10)  / 10 mL in 1 VIAL, MULTI-DOSE (63323-415-01)", "package_ndc": "63323-415-10", "marketing_start_date": "20150108"}], "brand_name": "Neostigmine Methylsulfate", "product_id": "63323-415_3abc0611-0e8c-49f9-9678-e4b2fda3d8ed", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "63323-415", "generic_name": "Neostigmine Methylsulfate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neostigmine Methylsulfate", "active_ingredients": [{"name": "NEOSTIGMINE METHYLSULFATE", "strength": "1 mg/mL"}], "application_number": "NDA203629", "marketing_category": "NDA", "marketing_start_date": "20150108", "listing_expiration_date": "20261231"}