Levora
- Product NDC
- 51862-097
- 11-digit product format
- 518620097
- Labeler code
- 51862
- Product ID
- 51862-097_3aadc382-e2a4-019e-e063-6394a90a45c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA073594
- Marketing category
- ANDA
- Marketing start
- 2016-08-03
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levora
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 238019, 748797, 748878, 748879 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51862-097-01 | Levora | 1 in 1 BLISTER PACK | KIT | 1 | 10 | |
| 51862-097-06 | Levora | 6 in 1 CARTON | KIT | 6 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-097-01 | EA - Each | 51862-097 | f0fced8a-54d1-4ec2-aa01-7f5a5aefacbb | 1 | 2016-11-08 |
| 51862-097-06 | EA - Each | 51862-097 | b0913047-ce14-45bf-bf7e-7679787d9145 | 1 | 2016-11-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 748879 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Levora 0.15/30 28 Day] | BPCK | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 748878 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 748878 | Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 748797 | inert 1 MG Oral Tablet | PSN | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 748879 | Levora 0.15/30 28 Day Pack | PSN | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 748879 | Levora 0.15/30 28 Day Pack | SY | 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3 | 10 |
| 748879 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Levora 0.15/30 28 Day] | BPCK | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 748878 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 748878 | Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 748797 | inert 1 MG Oral Tablet | PSN | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 748879 | Levora 0.15/30 28 Day Pack | PSN | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
| 748879 | Levora 0.15/30 28 Day Pack | SY | 0f2abab7-6dbe-4b18-b001-002b668eb370 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-097-01 | 51862009701 | 1 in 1 BLISTER PACK | Historical | |||||
| 51862-097-06 | 51862009706 | 6 BLISTER PACK in 1 CARTON (51862-097-06) > 1 KIT in 1 BLISTER PACK (51862-097-01) | 6 blister pack | 2016-08-03 | 0000-00-00 | No | No | Current |