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NDC 00536-1142-63 Levonorgestrel 1.5 mg/1 Details
Levonorgestrel 1.5 mg/1
Levonorgestrel is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is LEVONORGESTREL.
MedlinePlus Drug Summary
Levonorgestrel is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Levonorgestrel should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Levonorgestrel is in a class of medications called progestins. It works by preventing the release of an egg from the ovary or preventing fertilization of the egg by sperm (male reproductive cells). It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Levonorgestrel may prevent pregnancy, but it will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Related Packages: 00536-1142-63Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levonorgestrel
Product Information
| NDC | 00536-1142 |
|---|---|
| Product ID | 0536-1142_bea85d01-936e-46f6-8037-b60d0e39dd05 |
| Associated GPIs | 25400040000340 |
| GCN Sequence Number | 058193 |
| GCN Sequence Number Description | levonorgestrel TABLET 1.5 MG ORAL |
| HIC3 | G8A |
| HIC3 Description | CONTRACEPTIVES,ORAL |
| GCN | 23549 |
| HICL Sequence Number | 007318 |
| HICL Sequence Number Description | LEVONORGESTREL |
| Brand/Generic | Generic |
| Proprietary Name | Levonorgestrel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Levonorgestrel |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 1.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LEVONORGESTREL |
| Labeler Name | Rugby Laboratories |
| Pharmaceutical Class | Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202635 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00536-1142-63 (00536114263)
| NDC Package Code | 0536-1142-63 |
|---|---|
| Billing NDC | 00536114263 |
| Package | 1 BLISTER PACK in 1 CARTON (0536-1142-63) / 1 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2017-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 6.79659 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | LEVONORGESTREL 1.5 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL bea85d01-936e-46f6-8037-b60d0e39dd05 Details
Use
Warnings
Sexually transmitted diseases (STDs) alert
This product does not protect against HIV/AIDS or other STDs.
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.
Directions
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° to 25°C (68° to 77°F)
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
NDC 0536-1142-63
Rugby®
COMPARE TO
active ingredient in
PLAN B ONE-STEP®†
See New Warning
Levonorgestrel Tablet
1.5 mg
Emergency Contraceptive
- •
- Reduces the chance of pregnancy after unprotected sex
- •
- The sooner you take it, the more effective it will be
- •
-
Take as soon as possible within 72 hours (3 days) after
unprotected sex - •
- Will not harm an existing pregnancy
- •
- Not for regular birth control
1 Tablet Levonorgestrel 1.5 mg
ONE TABLET. ONE STEP.
INGREDIENTS AND APPEARANCE
| LEVONORGESTREL
levonorgestrel tablet |
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| Labeler - Rugby Laboratories (079246066) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | 725959238 | MANUFACTURE(0536-1142) | |