NDC 69536-103 Aftera
Levonorgestrel Tablet Oral

Product Information

Aftera is a human over the counter drug product labeled by Foundation Consumer Healthcare Llc. The generic name of Aftera is levonorgestrel. The product's dosage form is tablet and is administered via oral form.

Product Code69536-103
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.
Aftera
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
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 Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Foundation Consumer Healthcare Llc
Labeler Code69536
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.
NDA021998
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.
NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
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.
05-10-2018
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.
12-31-2022
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

What are the uses for Aftera?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)G00
Score1

Product Packages

NDC 69536-103-88

Package Description: 1 BLISTER PACK in 1 BOX, UNIT-DOSE > 1 TABLET in 1 BLISTER PACK

Price per Unit: $10.65938 per EA

Product Details

What are Aftera Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • LEVONORGESTREL 1.5 mg/1 - A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.

Aftera Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Aftera Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Aftera Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts

Manufactured by:
Gedeon Richter, Ltd., Budapest, Hungary


Active Ingredient



Levonorgestrel 1.5 mg


Purpose



Emergency contraceptive


Use



for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)


Allergy Alert



Do not use if you have ever had an allergic reaction to levonorgestrel


Sexually Transmitted Diseases (Stds) Alert



This product does not protect against HIV/AIDS or other STDs


Do Not Use



  • if you are already pregnant (because it will not work)
  • for regular birth control

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.


Otc - When Using



When using this product you may have

  • menstrual changes
  • tiredness
  • breast pain
  • nausea
  • headache
  • vomiting
  • lower stomach (abdominal) pain
  • dizziness

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.


Directions



  • take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.
  • if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose

Other Information



  • read the instructions, warnings and enclosed product leaflet before use
  • this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
  • do not use if carton is open or tear strip is removed or blister seal is broken or missing
  • store at 20-25°C (68-77°F)

Inactive Ingredients



colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc


Questions?



Call 1-888-919-0780


Principal Display Panel - 1.5 Mg Tablet Blister Pack Box



NDC 69536-103-88

Emergency Contraceptive
COMPARE TO PLAN B ONE-STEP®

Aftera®
LEVONORGESTREL 1.5 mg

Reduces chance of pregnancy
after unprotected sex.

One Tablet.
One Dose.

NOT FOR REGULAR BIRTH CONTROL

1 Tablet
Levonorgestrel
1.5 mg


* Please review the disclaimer below.