Osphena
- Product NDC
- 59630-580
- 11-digit product format
- 596300580
- Labeler code
- 59630
- Product ID
- 59630-580_0b4d6807-eb1c-4b86-9ee0-408fcdb55882
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ospemifene
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Shionogi Inc.
- Application
- NDA203505
- Marketing category
- NDA
- Marketing start
- 2013-02-26
- Marketing end
- 0000-00-00
- Substance
- OSPEMIFENE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OSPEMIFENE | ACTIVE INGREDIENT | B0P231ILBK | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| OSPEMIFENE | ACTIVE MOIETY | B0P231ILBK | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59630-580 | OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.] | 27 | Legacy NDC | 20230322_8462d6ab-e3cd-4efa-a360-75bf8f917287.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59630-580-18 | 59630058018 | 1 BLISTER PACK in 1 PACKAGE (59630-580-18) > 15 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2017-04-15 | 0000-00-00 | No | No | Current |
| 59630-580-55 | 59630058055 | 1 BLISTER PACK in 1 PACKAGE (59630-580-55) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2017-04-15 | 0000-00-00 | No | No | Current |
| 59630-580-90 | 59630058090 | 90 TABLET, FILM COATED in 1 BOTTLE (59630-580-90) | | 2013-02-26 | 0000-00-00 | No | No | Current |