NDC 68180-853 Fallback Solo

Levonorgestrel

NDC Product Code 68180-853

NDC CODE: 68180-853

Proprietary Name: Fallback Solo 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.

Drug Use Information

Drug Use 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.

  • Levonorgestrel is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This medication is an emergency contraceptive and should not be used as a regular form of birth control. It is a progestin hormone that 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. Using this medication will not stop an existing pregnancy or protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia). This medication may not work well in women over a certain weight (for example, greater than 164 pounds or 74 kilograms), or if you have used certain other medications within the past month. This effect can result in pregnancy. Talk to your doctor for more details and to see if this medication is right for you (see also Drug Interactions section). Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
LU;S25
Score: 1

NDC Code Structure

  • 68180 - Lupin Pharmaceuticals, Inc.

NDC 68180-853-13

Package Description: 1 BLISTER PACK in 1 CARTON > 1 TABLET in 1 BLISTER PACK (68180-853-11)

Price per Unit: $9.63661 per EA

NDC Product Information

Fallback Solo with NDC 68180-853 is a a human over the counter drug product labeled by Lupin Pharmaceuticals, Inc.. The generic name of Fallback Solo is levonorgestrel. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1543735 and 483325.

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.

Fallback Solo 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.


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.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: Lupin Pharmaceuticals, Inc.
Labeler Code: 68180
FDA Application Number: ANDA201446 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: 07-22-2014 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: 12-31-2021 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 - NO 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".

* Please review the disclaimer below.

Fallback Solo 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 1.5 mg

Purpose

Emergency contraceptive

Indications

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 levonorgestrel.Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDsDo not useif you are already pregnant (because it will not work)for regular birth controlAsk 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 changesnausealower stomach (abdominal) paintirednessheadachedizzinessbreast painvomiting

Otc - Keep Out Of Reach Of Children

This package is not child resistant. Keep this and all medication out of the reach of children. In case of overdose, get medical help or contact a Poison Control center right away.

Other

  • 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).tablet is enclosed in wallet seal. Do not use if the wallet seal is broken .store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].

Questions or comments? For more information call 1800-399-2561 or visit our website at www.birthcontrolhealth.com.

Fallback Solo™(levonorgestrel) Tablet, 1.5 mgEmergency ContraceptiveOne Tablet. One Dose.What You Need to Know

What is Fallback Solo™?Fallback Solo™ is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.What Fallback Solo is not.Fallback Solo will not work if you are already pregnant and will not affect an existing pregnancy. Fallback Solo will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

  • When not to use Fallback Solo?Fallback Solo should not be used:as a regular birth control method, because it's not as effective as regular birth control. if you are already pregnant, because it will not work.if you are allergic to levonorgestrel or any other ingredients in Fallback Solo.When should I talk to a doctor or 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 Fallback Solo and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.How does Fallback Solo work?Fallback Solo is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Fallback Solo contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Fallback Solo may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).How can I get the best results from Fallback Solo?You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Fallback Solo, the better it works. How effective is Fallback Solo?If Fallback Solo is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.How will I know Fallback Solo worked?You will know Fallback Solo has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.Will I experience any side effects?  some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.  If you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.  when used as directed, Fallback Solo is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.  if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.What if I still have questions about Fallback Solo?If you have questions or need more information, call our toll-free number, 1800-399-2561 or visit our website at www.birthcontrolhealth.com.Other InformationKeep this and all medication out of reach of children:In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.Do not use if the wallet seal is opened.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Active Ingredient: levonorgestrel 1.5 mgInactive Ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.Fallback Solo™ is a trademark of Lupin Pharmaceuticals, Inc.Distributed By:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by:Lupin LimitedPithampur (M.P.) - 454 775INDIARevised: September 18, 2017                                                                         ID#: 253402If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

Inactive Ingredients

Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

When Should I Use Fallback Solo?

  • The sooner you take emergency contraception, the better it works. You should use Fallback Solo within 72 hours (3 days) after you have had unprotected sex.Fallback Solo is a backup or emergency method of birth control you can use when:your regular birth control was used incorrectly or failed you did not use any birth control method

* Please review the disclaimer below.