Orsythia
- Product NDC
- 0254-2032
- 11-digit product format
- 002542032
- Labeler code
- 0254
- Product ID
- 0254-2032_d4e797ab-de31-4805-95f1-375f44f71465
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA201088
- Marketing category
- ANDA
- Marketing start
- 2018-04-15
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0254-2032-73 | EA - Each | 0254-2032 | 6c677af6-a6c3-4309-8e3c-506250814f67 | 1 | 2019-05-02 |
| 0254-2032-80 | EA - Each | 0254-2032 | 566f6837-3d5c-4ac3-966b-e06c0dd518ff | 1 | 2019-05-02 |
| 0254-2032-91 | EA - Each | 0254-2032 | 4a305a09-8e9e-4aef-aeae-102ef1b96366 | 1 | 2019-10-07 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1428933 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Orsythia 28 Day] | BPCK | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 1428933 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Orsythia 28 Day] | BPCK | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 748797 | inert 1 MG Oral Tablet | PSN | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 748797 | inert 1 MG Oral Tablet | PSN | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 1428933 | Orsythia 28 Day Pack | PSN | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 1428933 | Orsythia 28 Day Pack | PSN | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 1428933 | Orsythia 28 Day Pack | SY | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 1428933 | Orsythia 28 Day Pack | SY | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0254-2032-73 | 00254203273 | 3 CARTON in 1 CARTON (0254-2032-73) > 1 BLISTER PACK in 1 CARTON (0254-2032-91) > 1 KIT in 1 BLISTER PACK | 3 carton | 2018-04-15 | 0000-00-00 | No | No | Current |
| 0254-2032-80 | 00254203280 | 6 CARTON in 1 CARTON (0254-2032-80) > 1 BLISTER PACK in 1 CARTON (0254-2032-91) > 1 KIT in 1 BLISTER PACK | 6 carton | 2018-04-15 | 0000-00-00 | No | No | Current |