Levonorgestrel and Ethinyl Estradiol
- Product NDC
- 68180-854
- 11-digit product format
- 681800854
- Labeler code
- 68180
- Product ID
- 68180-854_fef28a30-7ad1-4c3c-a283-06f533374be4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA091425
- Marketing category
- ANDA
- Marketing start
- 2019-07-03
- 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
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 242297, 748797, 748868 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68180-854-73 | Levonorgestrel and Ethinyl Estradiol | 3 in 1 CARTON | KIT | 3 | 9 | |
| 68180-854-73 | Levonorgestrel and Ethinyl Estradiol | 1 in 1 BLISTER PACK | KIT | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68180-854-11 | EA - Each | 68180-854 | 42ee7fbb-69ea-4f95-b405-3729c173bbf5 | 1 | 2013-07-02 |
| 68180-854-13 | EA - Each | 68180-854 | 5117fd3a-3e84-4e85-89d8-e0fd6dbedc17 | 1 | 2013-07-02 |
| 68180-854-71 | EA - Each | 68180-854 | 5660cc29-38f6-461e-8df1-817283e4ae85 | 1 | 2019-11-12 |
| 68180-854-73 | EA - Each | 68180-854 | dd9b5b63-78db-442e-b5c2-8b63a59fd0df | 1 | 2019-11-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68180-854 | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250227_6e686b50-8d36-4a13-91a8-d4ad21cdb735.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 6e686b50-8d36-4a13-91a8-d4ad21cdb735 | 9 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 6e686b50-8d36-4a13-91a8-d4ad21cdb735 | 9 |
| 748797 | inert 1 MG Oral Tablet | PSN | 6e686b50-8d36-4a13-91a8-d4ad21cdb735 | 9 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 6e686b50-8d36-4a13-91a8-d4ad21cdb735 | 9 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | 6e686b50-8d36-4a13-91a8-d4ad21cdb735 | 9 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 6e686b50-8d36-4a13-91a8-d4ad21cdb735 | 9 |
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 9620a4dd-b61d-4fa6-863a-a262be253f06 | 1 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 9620a4dd-b61d-4fa6-863a-a262be253f06 | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | 9620a4dd-b61d-4fa6-863a-a262be253f06 | 1 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 9620a4dd-b61d-4fa6-863a-a262be253f06 | 1 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | 9620a4dd-b61d-4fa6-863a-a262be253f06 | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 9620a4dd-b61d-4fa6-863a-a262be253f06 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68180-854-13 | 68180085413 | 3 BLISTER PACK in 1 CARTON (68180-854-13) > 1 KIT in 1 BLISTER PACK (68180-854-11) | 3 blister pack | 2013-03-14 | 2021-03-31 | No | No | Current |
| 68180-854-73 | 68180085473 | 3 BLISTER PACK in 1 CARTON (68180-854-73) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2019-07-03 | 0000-00-00 | No | No | Current |