Orsythia
- Product NDC
- 53002-3647
- 11-digit product format
- 530023647
- Labeler code
- 53002
- Product ID
- 53002-3647_43272706-a1fd-49d7-a6ae-de0f7d8a57a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-3647-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-9d2b-0266-e053-dadaa90a7c1a | Orsythia ® (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only |
| 53002-3647-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-9d2b-0266-e053-dadaa90a7c1a | Orsythia ® (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only |
| 53002-3647-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-9d2b-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 |
|---|---|---|---|---|---|---|
| 53002-3647-1 | Orsythia | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 53002-3647-3 | Orsythia | 3 in 1 POUCH | KIT | 3 | 2 | |
| 53002-3647-3 | Orsythia | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 53002-3647-6 | Orsythia | 6 in 1 POUCH | KIT | 6 | 2 | |
| 53002-3647-6 | Orsythia | 1 in 1 BLISTER PACK | KIT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-3647 | ORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 2 | Legacy NDC, 5 package rows | 20201226_0a2775d0-8ca1-457f-9fbe-096f03aedc79.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 | 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 | 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 | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 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 | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 1428933 | Orsythia 28 Day Pack | PSN | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 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 | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
| 1428933 | Orsythia 28 Day Pack | SY | 0a2775d0-8ca1-457f-9fbe-096f03aedc79 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-3647-1 | 53002364701 | 1 KIT in 1 BLISTER PACK (53002-3647-1) | 1 kit | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-3647-3 | 53002364703 | 3 BLISTER PACK in 1 POUCH (53002-3647-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-3647-6 | 53002364706 | 6 BLISTER PACK in 1 POUCH (53002-3647-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |