Levora
- Product NDC
- 53002-1565
- 11-digit product format
- 530021565
- Labeler code
- 53002
- Product ID
- 53002-1565_ed1ead32-8b7e-4d9f-a56f-c7da8f3cef30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA073594
- Marketing category
- ANDA
- Marketing start
- 2016-08-03
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1565-1 | Levora | 1 in 1 BLISTER PACK | KIT | 1 | 4 | |
| 53002-1565-1 | Levora | 1 in 1 PACKAGE | KIT | 1 | 4 | |
| 53002-1565-3 | Levora | 1 in 1 BLISTER PACK | KIT | 1 | 4 | |
| 53002-1565-3 | Levora | 3 in 1 PACKAGE | KIT | 3 | 4 | |
| 53002-1565-6 | Levora | 6 in 1 PACKAGE | KIT | 6 | 4 | |
| 53002-1565-6 | Levora | 1 in 1 BLISTER PACK | KIT | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53002-1565-3 | EA - Each | 53002-1565 | c6d24d67-0604-4ef3-a50c-69affcc3edc3 | 1 | 2024-04-05 |
| 53002-1565-6 | EA - Each | 53002-1565 | b7ace11f-8511-448b-a25c-07fa40b5a97f | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1565 | LEVORA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 6 package rows | 20230609_0f2abab7-6dbe-4b18-b001-002b668eb370.zip |
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 | 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 |
|---|---|---|---|---|---|---|---|---|
| 53002-1565-1 | 53002156501 | 1 BLISTER PACK in 1 PACKAGE (53002-1565-1) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1565-3 | 53002156503 | 3 BLISTER PACK in 1 PACKAGE (53002-1565-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1565-6 | 53002156506 | 6 BLISTER PACK in 1 PACKAGE (53002-1565-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |