MARLISSA
- Product NDC
- 68462-388
- 11-digit product format
- 684620388
- Labeler code
- 68462
- Product ID
- 68462-388_c243946a-6bbb-4d5f-8081-1858771fe9de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA091452
- Marketing category
- ANDA
- Marketing start
- 2012-02-29
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MARLISSA
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238019, 748797, 748878, 1245919 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-388-29 | MARLISSA | 3 in 1 CARTON | KIT | 3 | | 14 |
| 68462-388-84 | MARLISSA | 1 in 1 BLISTER PACK | KIT | 1 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-388 | MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240104_9379d99e-c416-4dab-a817-1c110e0d4b93.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 |
|---|
| 68462-388-29 | 68462038829 | 3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84) | 3 blister pack | 2012-02-29 | 0000-00-00 | No | No | Current |
| 68462-388-84 | 68462038884 | 1 in 1 BLISTER PACK | | | | | | Historical |