Levonorgestrel 1.5 mg/1
Levonorgestrel · TABLET · Novel Laboratories, Inc.
Levonorgestrel is a tablet containing levonorgestrel at 1.5 mg/1, taken oral. Manufactured by Novel Laboratories, Inc..
Key Facts
- Brand Name
- Levonorgestrel
- Generic Name
- Levonorgestrel
- NDC Code (Product)
40032-622- Manufacturer
- Novel Laboratories, Inc.
- Strength
- 1.5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202508
- Drug Class
- Progestin [EPC]; Progestin-containing Intrauterine System [EPC]
- Marketing Start
- 02/15/2013
Recall History
Teva Pharmaceuticals USA, Inc.
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Mylan Pharmaceuticals Inc.
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Lupin Pharmaceuticals Inc.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Lupin Pharmaceuticals Inc.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Watson Laboratories Inc
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
L. Perrigo Company
Defective Container: Carton is missing the tablet blister strip and tablet.
Sandoz Incorporated
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Teva Pharmaceuticals USA, Inc.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use For women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
Dosage & Administration
When should I use Levonorgestrel Tablet? The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet within 72 hours (3 days) after you have had unprotected sex . Levonorgestrel tablet 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
Warnings
Warnings Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted disease (STDs) alert: This product does not protect against HIV/AIDS or other STDs
Frequently Asked Questions
What is Levonorgestrel used for?
Levonorgestrel contains Levonorgestrel. It is a tablet taken oral. Consult your doctor for specific uses.
Is Levonorgestrel a controlled substance?
Levonorgestrel is not classified as a controlled substance by the DEA.
What is the generic name for Levonorgestrel?
The generic name for Levonorgestrel is Levonorgestrel. There are 12 other brand versions of Levonorgestrel.
What is the NDC code for Levonorgestrel 1.5 mg/1?
The NDC (National Drug Code) for Levonorgestrel 1.5 mg/1 is 40032-622, listed by Novel Laboratories, Inc..
Other Levonorgestrel Brands
See all →- Morning After Pill1.5 mg/173436-8292
- Jolessa0555-9123
- camrese Lo0093-6148
- levonorgestrel and ethinyl estradiol42192-623
- My Way1.5 mg/143386-622
- Kurvelo50090-6374
- Econ Morning After1.5 mg/158602-841
- My Choice TM1.5 mg/162756-720
- Kurvelo68180-844
- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL0378-7284
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)