Amethyst
- Product NDC
- 52544-295
- 11-digit product format
- 525440295
- Labeler code
- 52544
- Product ID
- 52544-295_ffaba3df-086b-42fd-9469-80a43ffd8066
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA079218
- Marketing category
- ANDA
- Marketing start
- 2011-06-13
- Marketing end
- 0000-00-00
- Substance
- ETHINYL ESTRADIOL; LEVONORGESTREL
- Active strength
- 20 ug/1; ug/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52544-295-28 | 52544029528 | 1 POUCH in 1 CARTON (52544-295-28) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK | 1 pouch | 2011-06-13 | 0000-00-00 | No | No | Current |