Drospirenone and Ethinyl Estradiol
- Product NDC
- 59746-763
- 11-digit product format
- 597460763
- Labeler code
- 59746
- Product ID
- 59746-763_4219f41b-ed0d-4b19-86ee-5a5470b4d5b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Drospirenone and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Jubilant Cadista Pharmaceuticals Inc
- Application
- ANDA209423
- Marketing category
- ANDA
- Marketing start
- 2018-11-30
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 59746-763 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-763 | 59746-763-42 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-763 | 59746-763-43 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A209423-001 | DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET / ORAL | | | 2017-12-22 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59746-763-42 | 59746076342 | 1 BLISTER PACK in 1 PACKAGE (59746-763-42) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2018-11-30 | 0000-00-00 | No | No | Current |
| 59746-763-43 | 59746076343 | 1 BLISTER PACK in 1 PACKAGE (59746-763-43) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2018-11-30 | 0000-00-00 | No | No | Current |