Gianvi
- Product NDC
- 0093-5423
- 11-digit product format
- 000935423
- Labeler code
- 0093
- Product ID
- 0093-5423_86b80f5a-a800-4c2c-b5ad-41b5fb0f15d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Drospirenone and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Teva Pharmaceuticals USA Inc
- Application
- NDA021676
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2011-03-30
- Marketing end
- 2025-03-31
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-5423-28 | EA - Each | 0093-5423 | 20d5cbc7-9cd4-4551-9751-15a54f43f1c4 | 1 | 2013-02-13 |
| 0093-5423-58 | EA - Each | 0093-5423 | 4c970b64-6643-4444-b35b-d695d01a5cd5 | 1 | 2012-07-24 |
| 0093-5423-62 | EA - Each | 0093-5423 | df1def29-5d47-4c78-90e2-69d0b09cb155 | 1 | 2017-03-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DROSPIRENONE | ACTIVE INGREDIENT | N295J34A25 | GIANVI (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [MEDVANTX, INC.] | 1 | |
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | GIANVI (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [MEDVANTX, INC.] | 1 | |
| DROSPIRENONE | ACTIVE MOIETY | N295J34A25 | GIANVI (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [MEDVANTX, INC.] | 1 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | GIANVI (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [MEDVANTX, INC.] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993804 | {24 (drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack [Gianvi 28-Day] | BPCK | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 748798 | {24 (drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 748798 | Drospiren-Eth estra 3-0.02 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack | PSN | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 630734 | drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 993804 | Gianvi 28 Day Pack | PSN | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 630734 | drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral Tablet | SCD | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
| 993804 | Gianvi 28-Day Pack | SY | b61cdce5-9fb5-4901-a768-4282a684db3f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0093-5423-58 | 00093542358 | 3 BLISTER PACK in 1 PACKAGE (0093-5423-58) > 1 KIT in 1 BLISTER PACK (0093-5423-28) | 3 blister pack | 2011-03-30 | 2021-07-31 | No | No | Current |
| 0093-5423-62 | 00093542362 | 3 BLISTER PACK in 1 PACKAGE (0093-5423-62) > 1 KIT in 1 BLISTER PACK (0093-5423-28) | 3 blister pack | 2016-11-01 | 2025-03-31 | No | No | Current |