neostigmine methylsulfate

Generic: neostigmine methylsulfate

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

Drug Facts

Product Profile

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

neostigmine methylsulfate 1 mg/mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-9602
Product ID 0548-9602_32069cca-ad21-4afc-9c23-5ab376b0237a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209933
Listing Expiration 2026-12-31
Marketing Start 2017-09-25

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05489602
Hyphenated Format 0548-9602

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 ANDA209933 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 PACKAGE (0548-9602-00) / 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0548-9602-00 10 CARTON in 1 PACKAGE (0548-9602-00) / 1 VIAL, MULTI-DOSE in 1 CARTON / 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": "32069cca-ad21-4afc-9c23-5ab376b0237a", "openfda": {"unii": ["98IMH7M386"], "rxcui": ["311935", "311936"], "spl_set_id": ["e47a4a4c-0e7c-40b6-9950-5b3adadcac22"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 PACKAGE (0548-9602-00)  / 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0548-9602-00", "marketing_start_date": "20170925"}], "brand_name": "NEOSTIGMINE METHYLSULFATE", "product_id": "0548-9602_32069cca-ad21-4afc-9c23-5ab376b0237a", "dosage_form": "INJECTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "0548-9602", "generic_name": "neostigmine methylsulfate", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEOSTIGMINE METHYLSULFATE", "active_ingredients": [{"name": "NEOSTIGMINE METHYLSULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA209933", "marketing_category": "ANDA", "marketing_start_date": "20170925", "listing_expiration_date": "20261231"}