NDC 69452-243 Bionafem

Levonorgestrel

NDC Product Code 69452-243

NDC Code: 69452-243

Proprietary Name: Bionafem 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.

Non-Proprietary Name: Levonorgestrel 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.


Product Characteristics
Color(s):
WHITE (C48325 - OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
G;78
Score: 1

Code Structure
  • 69452 - Bionpharma Inc.
    • 69452-243 - Bionafem

NDC 69452-243-60

Package Description: 1 BLISTER PACK in 1 CARTON > 1 TABLET in 1 BLISTER PACK

NDC Product Information

Bionafem with NDC 69452-243 is a a human over the counter drug product labeled by Bionpharma Inc.. The generic name of Bionafem is levonorgestrel. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Bionpharma Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.


Bionafem Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LEVONORGESTREL 1.5 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, POTATO (UNII: 8I089SAH3T)
  • TALC (UNII: 7SEV7J4R1U)

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.

Labeler Name: Bionpharma Inc.
Labeler Code: 69452
FDA Application Number: ANDA207044 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 04-14-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Bionafem Product Label Images

Bionafem Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Levonorgestrel, USP 1.5mg

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)

Warnings

Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrelSexually 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

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.

When Using This Product You May Have

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

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 usethis 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 missingstore at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, potato starch, talc

* Please review the disclaimer below.

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