Synarel Spray, Metered
NDC Package 0025-0166-08

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

Package Information

Synarel (nafarelin acetate) sprays is nafarelin is used in women to treat a condition in which the tissue that normally lines the inside of the uterus grows in the wrong place (endometriosis). This formulation utilizes a spray, metered delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0025-0166 and is authorized under FDA application NDA019886.

Identification & Billing

NDC Package Code
0025-0166-08
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 8 mL in 1 BOTTLE, SPRAY
Product Code
0025-0166
11-Digit Billing Format
00025016608
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1797878 - nafarelin 200 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797878 - nafarelin 0.2 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797878 - nafarelin (as nafarelin acetate) 200 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797880 - Synarel 200 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797880 - nafarelin 0.2 MG/ACTUAT Metered Dose Nasal Spray [Synarel]

Clinical Specifications

Proprietary Name
Synarel
Non-Proprietary Name
Nafarelin Acetate
Substance Name
Nafarelin Acetate
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
NAFARELIN ACETATE 2 mg/mL
Pharmacologic Class
Usage Information
Nafarelin is used in women to treat a condition in which the tissue that normally lines the inside of the uterus grows in the wrong place (endometriosis). This medication helps to decrease the abnormal tissue and also the symptoms of endometriosis (such as pelvic pain, painful menstrual cramps, and pain during/after sex). This medication is also used in children to treat a certain type of early puberty (central precocious puberty, gonadotropin-dependent). It helps to slow the bone aging and height growth rate so that both are near normal, and it helps to stop or reverse signs of early puberty (such as breast growth in girls, growth of sexual organs in boys). Nafarelin is similar to a natural hormone made by the body (gonadotropin-releasing hormone-GnRH). It works by decreasing the testosterone hormones in boys and estrogen hormones in women and girls.

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA019886
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-13-1990
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0025-0166-08 identifies a specific commercial package of 1 bottle, spray in 1 carton / 8 ml in 1 bottle, spray of Synarel, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This spray, metered is formulated for nasal use and contains nafarelin acetate 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 Pfizer Laboratories Div Pfizer Inc on February 13, 1990. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Nafarelin is used in women to treat a condition in which the tissue that normally lines the inside of the uterus grows in the wrong place (endometriosis). This medication helps to decrease the abnormal tissue and also the symptoms of endometriosis (such as pelvic pain, painful menstrual cramps, and pain during/after sex). This medication is also used in children to treat a certain type of early puberty (central precocious puberty, gonadotropin-dependent). It helps to slow the bone aging and height growth rate so that both are near normal, and it helps to stop or reverse signs of early puberty (such as breast growth in girls, growth of sexual organs in boys). Nafarelin is similar to a natural hormone made by the body (gonadotropin-releasing hormone-GnRH). It works by decreasing the testosterone hormones in boys and estrogen hormones in women and girls.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00025016608. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0025-0166-08
11-Digit CMS (5-4-2)
00025-0166-08

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