neostigmine methylsulfate

Generic: neostigmine methylsulfate

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neostigmine methylsulfate
Generic Name neostigmine methylsulfate
Labeler indoco remedies limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

neostigmine methylsulfate .5 mg/mL

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-413
Product ID 14445-413_23ba06a5-8314-49cf-b9de-fa3caad1a17a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210652
Listing Expiration 2026-12-31
Marketing Start 2021-11-26

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14445413
Hyphenated Format 14445-413

Supplemental Identifiers

RxCUI
311935 311936
UPC
0314445414101 0314445413104
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 ANDA210652 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 PACKAGE (14445-413-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (14445-413-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

14445-413-01 10 CARTON in 1 PACKAGE (14445-413-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (14445-413-10) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

neostigmine methylsulfate (.5 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": "23ba06a5-8314-49cf-b9de-fa3caad1a17a", "openfda": {"upc": ["0314445414101", "0314445413104"], "unii": ["98IMH7M386"], "rxcui": ["311935", "311936"], "spl_set_id": ["6657402f-1db2-411e-bf66-fca3902756c4"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 PACKAGE (14445-413-01)  / 1 VIAL, MULTI-DOSE in 1 CARTON (14445-413-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "14445-413-01", "marketing_start_date": "20211126"}], "brand_name": "NEOSTIGMINE METHYLSULFATE", "product_id": "14445-413_23ba06a5-8314-49cf-b9de-fa3caad1a17a", "dosage_form": "INJECTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "14445-413", "generic_name": "NEOSTIGMINE METHYLSULFATE", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEOSTIGMINE METHYLSULFATE", "active_ingredients": [{"name": "NEOSTIGMINE METHYLSULFATE", "strength": ".5 mg/mL"}], "application_number": "ANDA210652", "marketing_category": "ANDA", "marketing_start_date": "20211126", "listing_expiration_date": "20261231"}