neostigmine methylsulfate

Generic: neostigmine methylsulfate

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neostigmine methylsulfate
Generic Name neostigmine methylsulfate
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

neostigmine methylsulfate .51 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-500
Product ID 71288-500_bf415978-8e01-4c77-e053-2995a90a9ea3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212804
Listing Expiration 2026-12-31
Marketing Start 2021-04-05

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288500
Hyphenated Format 71288-500

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 ANDA212804 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .51 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (71288-500-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-500-10)
source: ndc

Packages (1)

71288-500-11 10 VIAL, MULTI-DOSE in 1 CARTON (71288-500-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-500-10)

Ingredients (1)

neostigmine methylsulfate (.51 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": "bf415978-8e01-4c77-e053-2995a90a9ea3", "openfda": {"unii": ["98IMH7M386"], "rxcui": ["311935", "311936"], "spl_set_id": ["5a01a429-a346-4253-8994-b58d34b57974"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (71288-500-11)  / 10 mL in 1 VIAL, MULTI-DOSE (71288-500-10)", "package_ndc": "71288-500-11", "marketing_start_date": "20210405"}], "brand_name": "neostigmine methylsulfate", "product_id": "71288-500_bf415978-8e01-4c77-e053-2995a90a9ea3", "dosage_form": "INJECTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "71288-500", "generic_name": "neostigmine methylsulfate", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "neostigmine methylsulfate", "active_ingredients": [{"name": "NEOSTIGMINE METHYLSULFATE", "strength": ".51 mg/mL"}], "application_number": "ANDA212804", "marketing_category": "ANDA", "marketing_start_date": "20210405", "listing_expiration_date": "20261231"}