neostigmine methylsulfate

Generic: neostigmine methylsulfate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neostigmine methylsulfate
Generic Name neostigmine methylsulfate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

neostigmine methylsulfate 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-384
Product ID 68083-384_d23bd0d2-5553-4a34-bf15-81349c82eabe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212968
Listing Expiration 2026-12-31
Marketing Start 2019-10-21

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083384
Hyphenated Format 68083-384

Supplemental Identifiers

RxCUI
311935 311936
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 ANDA212968 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 CARTON (68083-384-10) / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-384-01) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-384-10 10 CARTON in 1 CARTON (68083-384-10) / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-384-01) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

neostigmine methylsulfate (1 mg/mL)

Linked Drug Pages (1)

Neostigmine methylsulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d23bd0d2-5553-4a34-bf15-81349c82eabe", "openfda": {"unii": ["98IMH7M386"], "rxcui": ["311935", "311936"], "spl_set_id": ["4eab6184-1771-4c15-a127-4eb3e47affc2"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 CARTON (68083-384-10)  / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-384-01)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-384-10", "marketing_start_date": "20191021"}], "brand_name": "Neostigmine methylsulfate", "product_id": "68083-384_d23bd0d2-5553-4a34-bf15-81349c82eabe", "dosage_form": "INJECTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "68083-384", "generic_name": "Neostigmine methylsulfate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neostigmine methylsulfate", "active_ingredients": [{"name": "NEOSTIGMINE METHYLSULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA212968", "marketing_category": "ANDA", "marketing_start_date": "20191021", "listing_expiration_date": "20261231"}