Amethia
- Product NDC
- 51862-047
- 11-digit product format
- 518620047
- Labeler code
- 51862
- Product ID
- 51862-047_129c30f2-85d6-59ee-e063-6294a90aef97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ETHINYL ESTRADIOL and LEVONORGESTREL
- Dosage form
- KIT
- Labeler
- Mayne Pharma Inc
- Application
- ANDA078834
- Marketing category
- ANDA
- Marketing start
- 2016-10-12
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amethia
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238019, 248310, 749761, 1112687 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51862-047-01 | Amethia | 1 in 1 BLISTER PACK | KIT | 1 | | 7 |
| 51862-047-91 | Amethia | 2 in 1 CARTON | KIT | 2 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-047 | AMETHIA (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MAYNE PHARMA INC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240302_d6a33ea7-ecd1-4f81-a984-f210a3989618.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 |
|---|
| 51862-047-01 | 51862004701 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51862-047-91 | 51862004791 | 2 BLISTER PACK in 1 CARTON (51862-047-91) > 1 KIT in 1 BLISTER PACK (51862-047-01) | 2 blister pack | 2016-10-12 | 0000-00-00 | No | No | Current |