Cryselle
- Product NDC
- 50090-2183
- 11-digit product format
- 500902183
- Labeler code
- 50090
- Product ID
- 50090-2183_cbabd0f6-72ca-4dd5-8b3f-9f1ad7c41c2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- A-S Medication Solutions
- Application
- ANDA075840
- Marketing category
- ANDA
- Marketing start
- 2002-07-24
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cryselle
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 311359, 748797, 749786, 750265 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2183-0 | 2023-02-07 | C162847 | 48780-1 | 9d75b9d0-3c8e-f424-e053-dadaa90a57ce | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 50090-2183-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-3c8e-f424-e053-dadaa90a57ce | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 50090-2183-0 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-3c8e-f424-e053-dadaa90a57ce | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 50090-2183-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3c8e-f424-e053-dadaa90a57ce | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2183-0 | Cryselle | 1 in 1 KIT | KIT | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2183-0 | EA - Each | 50090-2183 | f1d8550c-093a-4ab8-af66-8d8e094ded4f | 1 | 2019-02-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2183 | CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240511_fcf4f8ea-1eb3-4a43-87d2-16f93e904443.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 750265 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28] | BPCK | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 749786 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 750265 | Cryselle 28 Day Pack | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 749786 | eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 748797 | inert 1 MG Oral Tablet | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 311359 | norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 311359 | ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet | SCD | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 750265 | Cryselle 28 Day Pack | SY | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 311359 | ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral Tablet | SY | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-2183-0 | 50090218300 | 1 KIT in 1 KIT (50090-2183-0) | 1 kit | 2015-10-26 | 0000-00-00 | No | No | Current |