Neostigmine Methylsulfate Injection, Solution
NDC Package 43598-945-58

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Neostigmine Methylsulfate injection is a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery. This formulation utilizes a injection, solution delivery system. Marketed by Dr.reddys Laboratories Inc, this product is identified by NDC 43598-945 and is authorized under FDA application ANDA216291.

Identification & Billing

NDC Package Code
43598-945-58
Package Description
10 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK (43598-945-11) / 3 mL in 1 SYRINGE, GLASS
Product Code
43598-945
11-Digit Billing Format
43598094558
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2105413 - neostigmine methylsulfate 3 MG in 3 ML Prefilled Syringe
  • RxCUI: 2105413 - 3 ML neostigmine methylsulfate 1 MG/ML Prefilled Syringe
  • RxCUI: 2105413 - neostigmine methylsulfate 3 MG per 3 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Neostigmine Methylsulfate
Non-Proprietary Name
Neostigmine Methylsulfate
Substance Name
Neostigmine Methylsulfate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NEOSTIGMINE METHYLSULFATE 1 mg/mL
Pharmacologic Class
Usage Information
Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.

Regulatory & Marketing

Labeler Name
Dr.reddys Laboratories Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA216291
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-25-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43598-945-58 identifies a specific commercial package of 10 blister pack in 1 carton / 1 syringe, glass in 1 blister pack (43598-945-11) / 3 ml in 1 syringe, glass of Neostigmine Methylsulfate, a human prescription drug labeled by Dr.reddys Laboratories Inc. This injection, solution is formulated for intravenous use and contains neostigmine methylsulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Dr.reddys Laboratories Inc on July 25, 2022. The current certification is valid through December 31, 2026.

How is this Dr.reddys Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598094558. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
43598-945-58
11-Digit CMS (5-4-2)
43598-0945-58

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.