Osphena
- Product NDC
- 75929-178
- 11-digit product format
- 759290178
- Labeler code
- 75929
- Product ID
- 75929-178_d8109817-1594-59f0-e053-2a95a90ac0a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ospemifene
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pharma Packaging Solutions
- 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
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 75929-178-09 | 75929017809 | 90 TABLET, FILM COATED in 1 BOTTLE (75929-178-09) | 2013-02-26 | 0000-00-00 | No | No | Current | |
| 75929-178-95 | 75929017895 | 1 BLISTER PACK in 1 PACKAGE (75929-178-95) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2017-04-15 | 0000-00-00 | No | No | Current |