LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Product NDC
- 0378-7316
- 11-digit product format
- 003787316
- Labeler code
- 0378
- Product ID
- 0378-7316_ec0afe77-8394-9a0d-61c5-e2522c725ad9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206053
- Marketing category
- ANDA
- Marketing start
- 2017-10-02
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238019, 248310, 1373501, 1373502, 1373503 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7316-85 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 1 in 1 CARTON | KIT | 1 | | 7 |
| 0378-7316-85 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 1 in 1 POUCH | KIT | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7316 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250221_5c1d0a3a-1b24-44a0-9c53-224365b65945.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 |
|---|
| 0378-7316-85 | 00378731685 | 1 POUCH in 1 CARTON (0378-7316-85) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 1 pouch | 2017-10-02 | 0000-00-00 | No | No | Current |