VIORELE
- Product NDC
- 50090-1395
- 11-digit product format
- 500901395
- Labeler code
- 50090
- Product ID
- 50090-1395_fb1ff52e-d5ff-4ef2-9d1e-7dab6b047318
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- A-S Medication Solutions
- Application
- ANDA091346
- Marketing category
- ANDA
- Marketing start
- 2012-04-04
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VIORELE
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 248310, 249357, 748797, 759743, 1252016 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-1395-0 | 2023-02-07 | C162847 | 48780-1 | 9d75b9d0-6e3b-f424-e053-dadaa90a57ce | VIORELE |
| 50090-1395-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-6e3b-f424-e053-dadaa90a57ce | VIORELE |
| 50090-1395-0 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-6e3b-f424-e053-dadaa90a57ce | VIORELE |
| 50090-1395-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6e3b-f424-e053-dadaa90a57ce | VIORELE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1395-0 | VIORELE | 1 in 1 KIT | KIT | 1 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1395-0 | EA - Each | 50090-1395 | d358d236-1a0d-4c6d-bb6a-c7a9ca3cab6d | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1395 | VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] | 16 | Current NDC, Legacy NDC, 1 package rows | 20240516_6422dcc3-959a-4590-9ca8-9dcb58e68253.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1252016 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Viorele 28 Day] | BPCK | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 759743 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 759743 | Desogest-Eth estra 0.15-0.02 MG (21) Oral Tablet / Eth estra 0.01 MG (5) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day Pack | PSN | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | PSN | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 748797 | inert 1 MG Oral Tablet | PSN | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 1252016 | VIORELE 28 Day Pack | PSN | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | SCD | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | SCD | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 248310 | ethinyl estradiol 10 MCG Oral Tablet | SY | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
| 1252016 | Viorele 28 Day Pack | SY | 6422dcc3-959a-4590-9ca8-9dcb58e68253 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-1395-0 | 50090139500 | 1 KIT in 1 KIT (50090-1395-0) | 1 kit | 2014-11-28 | 0000-00-00 | No | No | Current |