Lincomycin Injection, Solution
NDC Package 70436-034-82

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

Package Information

Lincomycin injection is sterile solution is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. This formulation utilizes a injection, solution delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-034 and is authorized under FDA application ANDA216662.

Identification & Billing

NDC Package Code
70436-034-82
Package Description
10 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code
70436-034
11-Digit Billing Format
70436003482
RxNorm Crosswalk
  • RxCUI: 239212 - lincomycin 300 MG/ML Injectable Solution
  • RxCUI: 239212 - lincomycin (as lincomycin HCl) 300 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Lincomycin
Non-Proprietary Name
Lincomycin
Substance Name
Lincomycin
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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LINCOMYCIN 300 mg/mL
Usage Information
Lincomycin Injection sterile solution is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy.Lincomycin Injection may be administered concomitantly with other antimicrobial agents when indicated.Lincomycin Injection is not indicated in the treatment of minor bacterial infections or viral infections.To reduce the development of drug-resistant bacteria and maintain the effectiveness of lincomycin injection and other antibacterial drugs, lincomycin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216662
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-23-2023
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 70436-034-82 identifies a specific commercial package of 10 vial in 1 carton / 2 ml in 1 vial of Lincomycin, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. This injection, solution is formulated for intramuscular; intravenous use and contains lincomycin 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 Slate Run Pharmaceuticals, Llc on February 23, 2023. The current certification is valid through December 31, 2026.

How is this Slate Run Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436003482. 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)
70436-034-82
11-Digit CMS (5-4-2)
70436-0034-82

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