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NDC 50419-0422-01 Skyla 13.5 mg/1 Details
Skyla 13.5 mg/1
Skyla is a INTRAUTERINE INTRAUTERINE DEVICE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayer HealthCare Pharmaceuticals Inc.. The primary component is LEVONORGESTREL.
MedlinePlus Drug Summary
Levonorgestrel intrauterine system (Liletta, Kyleena, Mirena, Skyla) is used to prevent pregnancy. The Mirena brand intrauterine system is also used to treat heavy menstrual bleeding in women who want to use an intrauterine system to prevent pregnancy. Levonorgestrel is in a class of medications called hormonal contraceptives. Levonorgestrel intrauterine system works by thinning the lining of the uterus (womb) to prevent pregnancy from developing, thickening the mucus at the cervix (entrance to the uterus) to prevent sperm from entering, and preventing sperm from moving and surviving in the uterus. Levonorgestrel may also prevent ovulation (release of an egg from the ovaries) in some women. Levonorgestrel intrauterine system is an effective method of birth control but it does not prevent the spread of AIDS and other sexually transmitted diseases.
Related Packages: 50419-0422-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levonorgestrel Intrauterine System
Product Information
| NDC | 50419-0422 |
|---|---|
| Product ID | 50419-422_157ce370-1ff2-4a01-88bf-a1117aeb8c19 |
| Associated GPIs | 25200050005310 |
| GCN Sequence Number | 070461 |
| GCN Sequence Number Description | levonorgestrel IUD 14MCG/24HR INTRAUTERI |
| HIC3 | X1C |
| HIC3 Description | INTRA-UTERINE DEVICES (IUDS) |
| GCN | 33984 |
| HICL Sequence Number | 007318 |
| HICL Sequence Number Description | LEVONORGESTREL |
| Brand/Generic | Brand |
| Proprietary Name | Skyla |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Levonorgestrel |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INTRAUTERINE DEVICE |
| Route | INTRAUTERINE |
| Active Ingredient Strength | 13.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LEVONORGESTREL |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| 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 | NDA |
| Application Number | NDA203159 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50419-0422-01 (50419042201)
| NDC Package Code | 50419-422-01 |
|---|---|
| Billing NDC | 50419042201 |
| Package | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01) |
| Marketing Start Date | 2013-01-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |