Lutera
- Product NDC
- 51862-028
- 11-digit product format
- 518620028
- Labeler code
- 51862
- Product ID
- 51862-028_bf6c876c-12de-48e8-a9f2-cf74ee3338f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA076625
- 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
- Lutera
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 242297, 748797, 748868, 751884 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51862-028-01 | Lutera | 1 in 1 BLISTER PACK | KIT | 1 | 7 | |
| 51862-028-06 | Lutera | 6 in 1 CARTON | KIT | 6 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-028-01 | EA - Each | 51862-028 | 93fd91c7-fa83-4307-a955-47d7b5b9a8b2 | 1 | 2016-10-06 |
| 51862-028-06 | EA - Each | 51862-028 | 16806c94-b9e7-494e-adb0-f889c569e653 | 1 | 2016-10-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 751884 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Lutera 28 Day] | BPCK | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 748797 | inert 1 MG Oral Tablet | PSN | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 751884 | Lutera 28 Day Pack | PSN | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 751884 | Lutera 28 Day Pack | SY | b91ad328-f2f4-4f7d-82d3-daaada95f509 | 7 |
| 751884 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Lutera 28 Day] | BPCK | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 748797 | inert 1 MG Oral Tablet | PSN | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 751884 | Lutera 28 Day Pack | PSN | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
| 751884 | Lutera 28 Day Pack | SY | a8eaceb0-46bf-4d33-968d-a00684c86a39 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-028-01 | 51862002801 | 1 in 1 BLISTER PACK | Historical | |||||
| 51862-028-06 | 51862002806 | 6 BLISTER PACK in 1 CARTON (51862-028-06) > 1 KIT in 1 BLISTER PACK (51862-028-01) | 6 blister pack | 2016-08-03 | 0000-00-00 | No | No | Current |