Doxycycline Hyclate Powder, For Solution
NDC Package 70436-032-82

11-digit billing NDC: 70436003282 · Billing unit: EA · 10 EA per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Doxycycline Hyclate powders is to reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a powder, for solution delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-032 and is authorized under FDA application ANDA217685.

Identification & Billing

NDC Package Code
70436-032-82
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (70436-032-35)
Product Code
70436-032
11-Digit Billing Format
70436003282
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA

Clinical Specifications

Proprietary Name
Doxycycline Hyclate
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Anhydrous
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOXYCYCLINE ANHYDROUS 100 mg/10mL
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP 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.Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms:Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers).Mycoplasma pneumoniae(PPLO, Eaton Agent). Agents of psittacosis and ornithosis.Agents of lymphogranuloma venereum and granuloma inguinale.The spirochetal agent of relapsing fever ( Borrelia recurrentis). The following gram-negative microorganisms:Haemophilus ducreyi(chancroid). Yersinia pestis.Francisella tularensis. Bartonella bacilliformis. Bacteroidesspecies. Vibrio cholerae.Campylobacter fetus. Brucellaspecies (in conjunction with streptomycin). Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli. Enterobacter aerogenesShigellaspecies. Acinetobacterspecies. Haemophilus influenzae(respiratory infections). Klebsiellaspecies (respiratory and urinary infections). Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Streptococcusspecies Up to 44 percent of strains of Streptococcus pyogenesand 74 percent of Enterococcus faecalishave been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive. For upper respiratory infections due to group A beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever.Streptococcus pneumoniae. Staphylococcus aureus, respiratory, skin and soft tissue infections. Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to:Neisseria gonorrhoeaeand N. meningitidis. Treponema pallidumand Treponema pertenue(syphilis and yaws). Listeria monocytogenes.Clostridiumspecies. Fusobacterium fusiforme(Vincent's infection). Actinomycesspecies. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.

Regulatory & Marketing

Labeler Name
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217685
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-22-2024
Listing Expiration
12-31-2027
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1271
Source: ASP
Inj doxycycline hyclate 1 mg
HCPCS Dosage 1 MG
Units / Pkg 1000

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 70436-032-82 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (70436-032-35) of Doxycycline Hyclate, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This powder, for solution is formulated for intravenous use and contains doxycycline anhydrous 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 July 22, 2024. The current certification is valid through December 31, 2027.

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: 70436003282. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. 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)
70436-032-82
11-Digit CMS (5-4-2)
70436-0032-82

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