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NDC 00074-0039-14 Orilissa 200 mg/1 Details
Orilissa 200 mg/1
Orilissa is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AbbVie Inc.. The primary component is ELAGOLIX SODIUM.
MedlinePlus Drug Summary
Elagolix is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding). Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of certain hormones in the body.
Related Packages: 00074-0039-14Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Elagolix
Product Information
| NDC | 00074-0039 |
|---|---|
| Product ID | 0074-0039_0c3c5812-03a4-4ff2-bc62-786488dc4cc4 |
| Associated GPIs | 30090030100330 |
| GCN Sequence Number | 078659 |
| GCN Sequence Number Description | elagolix sodium TABLET 200 MG ORAL |
| HIC3 | P1N |
| HIC3 Description | LHRH(GNRH) ANTAGONIST,PITUITARY SUPPRESSANT AGENTS |
| GCN | 45028 |
| HICL Sequence Number | 045108 |
| HICL Sequence Number Description | ELAGOLIX SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | Orilissa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Elagolix |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | ELAGOLIX SODIUM |
| Labeler Name | AbbVie Inc. |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210450 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00074-0039-14 (00074003914)
| NDC Package Code | 0074-0039-14 |
|---|---|
| Billing NDC | 00074003914 |
| Package | 1 BLISTER PACK in 1 CARTON (0074-0039-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2018-07-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |