Ashlyna
- Product NDC
- 68462-646
- 11-digit product format
- 684620646
- Labeler code
- 68462
- Product ID
- 68462-646_8ba0405a-4148-4c5c-80f1-28c73ebb41a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA203163
- Marketing category
- ANDA
- Marketing start
- 2015-02-23
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ashlyna
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238019, 248310, 749761, 1603861 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-646-91 | Ashlyna | 1 in 1 BLISTER PACK | KIT | 1 | | 10 |
| 68462-646-93 | Ashlyna | 1 in 1 POUCH | KIT | 1 | | 10 |
| 68462-646-93 | Ashlyna | 2 in 1 CARTON | KIT | 2 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-646 | ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 9 | Current NDC, Legacy NDC, 3 package rows | 20230328_407a9f63-9abf-4886-864a-d3dd0e429762.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 |
|---|
| 68462-646-91 | 68462064691 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68462-646-93 | 68462064693 | 2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91) | 2 pouch | 2015-02-23 | 0000-00-00 | No | No | Current |