Gianvi
- Product NDC
- 66116-470
- 11-digit product format
- 661160470
- Labeler code
- 66116
- Product ID
- 66116-470_b61cdce5-9fb5-4901-a768-4282a684db3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Drospirenone and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- MedVantx, Inc.
- Application
- NDA021676
- Marketing category
- NDA
- Marketing start
- 2010-10-22
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66116-470-28 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b885-f6ea-e053-dbdaa90aa703 | Gianvi TM (drospirenone and ethinyl estradiol) Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66116-470-28 | Gianvi | 3 in 1 PACKAGE | KIT | 3 | 1 | |
| 66116-470-28 | Gianvi | 1 in 1 BLISTER PACK | KIT | 1 | 1 |
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 Dashboard NDC Coverage#
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 | Status |
|---|---|---|---|
| 66116-470-28 | 66116047028 | 3 in 1 PACKAGE | Historical |