NDC 59630-580
Osphena
Ospemifene
Osphena is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Shionogi Inc.. The primary component is Ospemifene.
| Product ID | 59630-580_0b4d6807-eb1c-4b86-9ee0-408fcdb55882 |
| NDC | 59630-580 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Osphena |
| Generic Name | Ospemifene |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-02-26 |
| Marketing Category | NDA / DRUG FOR FURTHER PROCESSING |
| Application Number | NDA203505 |
| Labeler Name | Shionogi Inc. |
| Substance Name | OSPEMIFENE |
| Active Ingredient Strength | 60 mg/1 |
| Pharm Classes | Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 59630-580-18
1 BLISTER PACK in 1 PACKAGE (59630-580-18) > 15 TABLET, FILM COATED in 1 BLISTER PACK
| Marketing Start Date | 2017-04-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59630-580-10 [59630058010]
OSPHENA TABLET
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-02-26 |
| Marketing End Date | 2014-10-10 |
NDC 59630-580-55 [59630058055]
OSPHENA TABLET
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-04-15 |
NDC 59630-580-18 [59630058018]
OSPHENA TABLET
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-04-15 |
NDC 59630-580-90 [59630058090]
OSPHENA TABLET
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-02-26 |
NDC 59630-580-00 [59630058000]
OSPHENA TABLET
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-02-26 |
| Marketing End Date | 2014-05-13 |
NDC 59630-580-50 [59630058050]
OSPHENA TABLET
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-02-26 |
| Marketing End Date | 2014-05-13 |
NDC 59630-580-30 [59630058030]
OSPHENA TABLET
| Marketing Category | NDA |
| Application Number | NDA203505 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-02-26 |
| Marketing End Date | 2017-04-07 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| OSPEMIFENE | 60 mg/1 |
Medicade Reported Pricing
59630058090 OSPHENA 60 MG TABLET
Pricing Unit: EA | Drug Type:
59630058030 OSPHENA 60 MG TABLET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "Osphena" or generic name "Ospemifene"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 59630-580 | Osphena | Ospemifene |
| 75929-178 | Osphena | Ospemifene |
Trademark Results [Osphena]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSPHENA 85593625 4455815 Live/Registered |
DUCHESNAY INC. 2012-04-10 |
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