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 76045-214
Product ID 76045-214_27e94d4f-f8d8-437a-a770-7020a9f8f61d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203629
Listing Expiration 2026-12-31
Marketing Start 2018-09-18

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045214
Hyphenated Format 76045-214

Supplemental Identifiers

RxCUI
2105413
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 BLISTER PACK in 1 CARTON (76045-214-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-214-00) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76045-214-30 10 BLISTER PACK in 1 CARTON (76045-214-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-214-00) / 3 mL in 1 SYRINGE, GLASS

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": "27e94d4f-f8d8-437a-a770-7020a9f8f61d", "openfda": {"unii": ["98IMH7M386"], "rxcui": ["2105413"], "spl_set_id": ["b0b509c3-8dc8-48cc-b7a8-16b93ad706c6"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (76045-214-30)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-214-00)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-214-30", "marketing_start_date": "20220601"}], "brand_name": "Neostigmine Methylsulfate", "product_id": "76045-214_27e94d4f-f8d8-437a-a770-7020a9f8f61d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "76045-214", "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": "20180918", "listing_expiration_date": "20261231"}