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NDC 55494-0580-55 Osphena 60 mg/1 Details
Osphena 60 mg/1
Osphena is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Duchesnay USA, Inc.. The primary component is OSPEMIFENE.
MedlinePlus Drug Summary
Ospemifene is used to treat changes due to menopause (''change of life,'' the end of monthly menstrual periods) in and around the vagina that can cause painful sexual intercourse and vaginal dryness. Ospemifene is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
Related Packages: 55494-0580-55Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Ospemifene
Product Information
| NDC | 55494-0580 |
|---|---|
| Product ID | 55494-580_e85d61c1-b94b-4188-9bc6-01e0f467d5e9 |
| Associated GPIs | |
| GCN Sequence Number | 070705 |
| GCN Sequence Number Description | ospemifene TABLET 60 MG ORAL |
| HIC3 | G1E |
| HIC3 Description | MENOPAUSAL SYMPT SUPP-SEL ESTROGEN RECEP MODULATOR |
| GCN | 34336 |
| HICL Sequence Number | 040096 |
| HICL Sequence Number Description | OSPEMIFENE |
| Brand/Generic | Brand |
| Proprietary Name | Osphena |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ospemifene |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 60 |
| Active Ingredient Units | mg/1 |
| Substance Name | OSPEMIFENE |
| Labeler Name | Duchesnay USA, Inc. |
| Pharmaceutical Class | Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55494-0580-55 (55494058055)
| NDC Package Code | 55494-580-55 |
|---|---|
| Billing NDC | 55494058055 |
| Package | 1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2023-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |