Levonorgestrel and Ethinyl Estradiol
- Product NDC
- 68462-637
- 11-digit product format
- 684620637
- Labeler code
- 68462
- Product ID
- 68462-637_ed921f2c-7961-477a-bbac-2e666d32e3ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA202791
- Marketing category
- ANDA
- Marketing start
- 2015-04-09
- Substance
- ETHINYL ESTRADIOL; LEVONORGESTREL
- Active strength
- 20; 90 ug/1; ug/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levonorgestrel and Ethinyl Estradiol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 20 ug/1 |
| LEVONORGESTREL | 90 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 5W7SIA7YZW |
| Rxcui | 722152, 751553 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-637-29 | Levonorgestrel and Ethinyl Estradiol | 3 in 1 CARTON | TABLET | 3 | | 10 |
| 68462-637-84 | Levonorgestrel and Ethinyl Estradiol | 1 in 1 POUCH | TABLET | 1 | | 10 |
| 68462-637-84 | Levonorgestrel and Ethinyl Estradiol | 28 in 1 BLISTER PACK | TABLET | 28 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-637 | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240104_44fbc5ae-5682-471f-a12a-955e8b4d233a.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 |
|---|
| 68462-637-29 | 68462063729 | 3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACK | 3 pouch | 2015-04-09 | 0000-00-00 | No | No | Current |
| 68462-637-84 | 68462063784 | 1 in 1 POUCH | | | | | | Historical |