Progesterone Injection, Solution
NDC Package 70700-286-22

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

Package Information

Progesterone injection is progesterone is a type of female hormone (progestin). This formulation utilizes a injection, solution delivery system. Marketed by Xiromed, Llc, this product is identified by NDC 70700-286 and is authorized under FDA application ANDA215634.

Identification & Billing

NDC Package Code
70700-286-22
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
70700-286
11-Digit Billing Format
70700028622
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
RxCUI: 312644 - progesterone 50 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Progesterone
Non-Proprietary Name
Progesterone
Substance Name
Progesterone
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.
Active Ingredient(s)
PROGESTERONE 50 mg/mL
Pharmacologic Class
Usage Information
Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

Regulatory & Marketing

Labeler Name
Xiromed, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215634
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2022
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.

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.

J2675
Source: PDAC
INJECTION, PROGESTERONE, PER 50 MG
HCPCS Dosage 50 MG
Units / Pkg

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 70700-286-22 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Progesterone, a human prescription drug labeled by Xiromed, Llc. This injection, solution is formulated for intramuscular use and contains progesterone 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 Xiromed, Llc on March 29, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

How is this Xiromed, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70700028622. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
70700-286-22
11-Digit CMS (5-4-2)
70700-0286-22

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