Volnea
- Product NDC
- 63629-2449
- 11-digit product format
- 636292449
- Labeler code
- 63629
- Product ID
- 63629-2449_50ece9ce-fedb-4a45-9ac6-e4253fcab02c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desogestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202689
- Marketing category
- ANDA
- Marketing start
- 2017-12-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Volnea
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 248310, 249357, 748797, 759743, 2001756 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-2449-1 | Volnea | 1 in 1 BLISTER PACK | KIT | 1 | 103 | |
| 63629-2449-1 | Volnea | 3 in 1 CARTON | KIT | 3 | 103 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2449-1 | EA - Each | 63629-2449 | 66e1d9df-d429-433b-9539-86d40853789c | 1 | 2021-07-15 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-2449 | VOLNEA (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 2 package rows | 20240112_0e65209d-329a-4d31-8afb-24348dc8d7e7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2001756 | {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 [Volnea 28 Day] | BPCK | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 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 | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 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 | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | PSN | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 748797 | inert 1 MG Oral Tablet | PSN | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 2001756 | Volnea 28 Day Pack | PSN | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | SCD | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | SCD | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 248310 | ethinyl estradiol 10 MCG Oral Tablet | SY | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
| 2001756 | Volnea 28 Day Pack | SY | 0e65209d-329a-4d31-8afb-24348dc8d7e7 | 103 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-2449-1 | 63629244901 | 3 BLISTER PACK in 1 CARTON (63629-2449-1) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2021-04-27 | 0000-00-00 | No | No | Current |