Doxycycline Injection, Powder, Lyophilized, For Solution
NDC Package 70748-338-10

11-digit billing NDC: 70748033810 · Billing unit: EA · 10 EA per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Doxycycline injection is to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection 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 injection, powder, lyophilized, for solution delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 70748-338 and is authorized under FDA application ANDA217794.

Identification & Billing

NDC Package Code
70748-338-10
Package Description
10 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
70748-338
11-Digit Billing Format
70748033810
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk
RxCUI: 310027 - doxycycline hyclate 100 MG Injection

Clinical Specifications

Proprietary Name
Doxycycline
Non-Proprietary Name
Doxycycline
Substance Name
Doxycycline Hyclate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 100 mg/10mL
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for 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.Doxycycline 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,Bacteroides species,Vibrio cholerae andCampylobacter fetus,Brucella species (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 aerogenes,Shigella species,Acinetobacter species,Haemophilus influenzae (respiratory infections),Klebsiella species (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:

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217794
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2024
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 70748-338-10 identifies a specific commercial package of 10 vial in 1 carton / 10 ml in 1 vial of Doxycycline, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains doxycycline hyclate 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 Lupin Pharmaceuticals, Inc. on May 31, 2024. The current certification is valid through December 31, 2027.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70748033810. 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)
70748-338-10
11-Digit CMS (5-4-2)
70748-0338-10

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