Amethyst
- Product NDC
- 0480-3472
- 11-digit product format
- 004803472
- Labeler code
- 0480
- Product ID
- 0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA079218
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- Substance
- ETHINYL ESTRADIOL; LEVONORGESTREL
- Active strength
- 20; 90 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 System [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amethyst
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 20 ug/1 |
| LEVONORGESTREL | 90 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 5W7SIA7YZW |
| Rxcui | 722152, 751553, 1112715 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-3472-24 | Amethyst | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 0480-3472-24 | Amethyst | 1 in 1 POUCH | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-3472 | AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230307_99073fe0-eac8-44dd-abe6-623fa67d9e79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0480-3472-24 | 00480347224 | 1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK | 1 pouch | 2023-03-01 | 0000-00-00 | No | No | Current |