DROSPIRENONE AND ETHINYL ESTRADIOL
- Product NDC
- 0378-7300
- 11-digit product format
- 003787300
- Labeler code
- 0378
- Product ID
- 0378-7300_29e77a5a-0e9f-2c5b-efd5-2fbbd10ae63f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- drospirenone and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202131
- Marketing category
- ANDA
- Marketing start
- 2015-08-28
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DROSPIRENONE AND ETHINYL ESTRADIOL
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 284207, 748797, 748800 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7300-53 | DROSPIRENONE AND ETHINYL ESTRADIOL | 3 in 1 CARTON | KIT | 3 | | 12 |
| 0378-7300-85 | DROSPIRENONE AND ETHINYL ESTRADIOL | 1 in 1 BLISTER PACK | KIT | 1 | | 12 |
| 0378-7300-85 | DROSPIRENONE AND ETHINYL ESTRADIOL | 1 in 1 POUCH | KIT | 1 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7300 | DROSPIRENONE AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250221_25f9b952-cc1d-454e-a3ec-834ba1774b6b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-7300-53 | 00378730053 | 3 POUCH in 1 CARTON (0378-7300-53) / 1 BLISTER PACK in 1 POUCH (0378-7300-85) / 1 KIT in 1 BLISTER PACK | 3 pouch | 2015-08-28 | 0000-00-00 | No | No | Current |
| 0378-7300-85 | 00378730085 | 1 in 1 BLISTER PACK | | | | | | Historical |