Drospirenone and Ethinyl Estradiol
- Product NDC
- 59746-764
- 11-digit product format
- 597460764
- Labeler code
- 59746
- Product ID
- 59746-764_112b5b5c-0106-4f69-a4d7-5319fcc94563
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Drospirenone and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Jubilant Cadista Pharmaceuticals Inc
- Application
- ANDA210017
- Marketing category
- ANDA
- Marketing start
- 2018-12-31
- Marketing end
- 2021-06-30
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 59746-764 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-764 | 59746-764-42 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-764 | 59746-764-43 | 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 |
|---|
| A210017-001 | DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET / ORAL-28 | | | 2018-09-10 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59746-764-42 | 59746076442 | 1 BLISTER PACK in 1 PACKAGE (59746-764-42) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2018-12-31 | 2021-06-30 | No | No | Current |
| 59746-764-43 | 59746076443 | 3 BLISTER PACK in 1 PACKAGE (59746-764-43) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2018-12-31 | 2021-06-30 | No | No | Current |