Neostigmine Methylsulfate Injection
NDC Package 14445-413-01

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 indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. This formulation utilizes a injection delivery system. Marketed by Indoco Remedies Limited, this product is identified by NDC 14445-413 and is authorized under FDA application ANDA210652.

Identification & Billing

NDC Package Code
14445-413-01
Package Description
10 CARTON in 1 PACKAGE / 1 VIAL, MULTI-DOSE in 1 CARTON (14445-413-10) / 10 mL in 1 VIAL, MULTI-DOSE
Product Code
14445-413
11-Digit Billing Format
14445041301
RxNorm Crosswalk
  • RxCUI: 311935 - neostigmine methylsulfate 0.5 MG/ML Injectable Solution
  • RxCUI: 311936 - neostigmine methylsulfate 1 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Neostigmine Methylsulfate
Non-Proprietary Name
Neostigmine Methylsulfate
Substance Name
Neostigmine Methylsulfate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NEOSTIGMINE METHYLSULFATE .5 mg/mL
Pharmacologic Class
Usage Information
Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

Regulatory & Marketing

Labeler Name
Indoco Remedies Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA210652
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-26-2021
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 14445-413-01 identifies a specific commercial package of 10 carton in 1 package / 1 vial, multi-dose in 1 carton (14445-413-10) / 10 ml in 1 vial, multi-dose of Neostigmine Methylsulfate, a human prescription drug labeled by Indoco Remedies Limited. This injection 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 Indoco Remedies Limited on November 26, 2021. The current certification is valid through December 31, 2026.

How is this Indoco Remedies Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14445041301. 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)
14445-413-01
11-Digit CMS (5-4-2)
14445-0413-01

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