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NDC 50090-5422-00 Ella 30 mg/1 Details
Ella 30 mg/1
Ella is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by A-S Medication Solutions. The primary component is ULIPRISTAL ACETATE.
MedlinePlus Drug Summary
Ulipristal 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]). Ulipristal 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. Ulipristal is in a class of medications called progestins. It works by preventing or delaying the release of an egg from the ovary. It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Ulipristal 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: 50090-5422-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ulipristal
Product Information
| NDC | 50090-5422 |
|---|---|
| Product ID | 50090-5422_cb78d0c3-de38-40ed-a74b-8391b860e1cb |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Ella |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ulipristal acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/1 |
| Substance Name | ULIPRISTAL ACETATE |
| Labeler Name | A-S Medication Solutions |
| Pharmaceutical Class | Progesterone Agonist/Antagonist [EPC], Selective Progesterone Receptor Modulators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022474 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50090-5422-00 (50090542200)
| NDC Package Code | 50090-5422-0 |
|---|---|
| Billing NDC | 50090542200 |
| Package | 1 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2021-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |