Orsythia
- Product NDC
- 50090-4303
- 11-digit product format
- 500904303
- Labeler code
- 50090
- Product ID
- 50090-4303_99408665-a3a4-47fa-a4c8-8241eab4efe5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- A-S Medication Solutions
- 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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4303-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-da49-0266-e053-dadaa90a7c1a | Orsythia ® (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4303-0 | Orsythia | 1 in 1 KIT | KIT | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4303-0 | EA - Each | 50090-4303 | da007b4a-c846-4253-9079-e2415d046f0a | 1 | 2022-04-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4303 | ORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] | 2 | Legacy NDC, 1 package rows | 20191003_18d1c61e-4bce-4535-b8a2-dbde268875d4.zip |
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 | 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 | 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 | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 748797 | inert 1 MG Oral Tablet | PSN | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 2 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 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 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 18d1c61e-4bce-4535-b8a2-dbde268875d4 | 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 |
|---|---|---|---|---|---|---|---|---|
| 50090-4303-0 | 50090430300 | 1 KIT in 1 KIT (50090-4303-0) | 1 kit | 2019-05-17 | 0000-00-00 | No | No | Current |