Zovia 1/35
- Product NDC
- 53002-1591
- 11-digit product format
- 530021591
- Labeler code
- 53002
- Product ID
- 53002-1591_edf00d60-af35-4f64-ae7d-a9d07782392d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ethynodiol Diacetate and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA076785
- Marketing category
- ANDA
- Marketing start
- 2016-07-18
- 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1591-1 | Zovia 1/35 | 1 in 1 PACKAGE | KIT | 1 | 3 | |
| 53002-1591-1 | Zovia 1/35 | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 53002-1591-3 | Zovia 1/35 | 3 in 1 PACKAGE | KIT | 3 | 3 | |
| 53002-1591-3 | Zovia 1/35 | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 53002-1591-6 | Zovia 1/35 | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 53002-1591-6 | Zovia 1/35 | 6 in 1 PACKAGE | KIT | 6 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1591 | ZOVIA 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 6 package rows | 20201217_d5a2cb17-0807-4529-bd6e-d311e06fc460.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 748859 | {21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Zovia 1/35E 28 Day] | BPCK | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 748804 | {21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 748804 | Eth estra-Ethyn 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 310228 | ethynodiol diacetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet | PSN | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 748797 | inert 1 MG Oral Tablet | PSN | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 748859 | Zovia 1/35E 28 Day Pack | PSN | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 310228 | ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet | SCD | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 310228 | ethinyl estradiol 35 MCG / ethynodiol 1 MG Oral Tablet | SY | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
| 748859 | Zovia 1/35E 28 Day Pack | SY | d5a2cb17-0807-4529-bd6e-d311e06fc460 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-1591-1 | 53002159101 | 1 BLISTER PACK in 1 PACKAGE (53002-1591-1) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1591-3 | 53002159103 | 3 BLISTER PACK in 1 PACKAGE (53002-1591-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1591-6 | 53002159106 | 6 BLISTER PACK in 1 PACKAGE (53002-1591-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |