NDC 65862-849-88 Afirmelle
Levonorgestrel And Ethinyl Estradiol Kit

Package Information

The NDC Code 65862-849-88 is assigned to a package of 3 pouch in 1 carton > 1 blister pack in 1 pouch (65862-849-28) > 1 kit in 1 blister pack of Afirmelle, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is kit and is administered via form.

Field Name Field Value
NDC Code 65862-849-88
Package Description 3 POUCH in 1 CARTON > 1 BLISTER PACK in 1 POUCH (65862-849-28) > 1 KIT in 1 BLISTER PACK
Product Code 65862-849
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Afirmelle
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Levonorgestrel And Ethinyl Estradiol
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
65862084988
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Estimated Billable Units per Package 3 EA
NADAC Wholesale Price per Unit National Average Drug Acquisition Cost (NADAC)
The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 65862-849-88 is $0.24747 and is up-to-date as of 11-23-2022. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $
$0.24747
NDC to RxNorm Crosswalk
  • RxCUI: 1860414 - {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Afirmelle 28 Day]
  • RxCUI: 1860414 - Afirmelle 28 Day Kit
  • RxCUI: 242297 - levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 242297 - ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • Product Type What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
    Human Prescription Drug
    Labeler Name Aurobindo Pharma Limited
    Dosage Form Kit - A packaged collection of related material.
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    FDA Application Number What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
    ANDA206886
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    11-14-2016
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    12-31-2023
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC Code Structure

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for Afirmelle with product NDC 65862-849.

    NDC Package CodePackage Description
    65862-849-926 POUCH in 1 CARTON > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.