levonorgestrel and ethinyl estradiol
- Product NDC
- 68462-672
- 11-digit product format
- 684620672
- Labeler code
- 68462
- Product ID
- 68462-672_f0db17c7-0387-420c-8ba4-5d0752e5a4ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA203164
- Marketing category
- ANDA
- Marketing start
- 2015-06-12
- 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
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238019, 748797, 751901 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-672-91 | levonorgestrel and ethinyl estradiol | 1 in 1 BLISTER PACK | KIT | 1 | | 6 |
| 68462-672-91 | levonorgestrel and ethinyl estradiol | 1 in 1 POUCH | KIT | 1 | | 6 |
| 68462-672-95 | levonorgestrel and ethinyl estradiol | 3 in 1 CARTON | KIT | 3 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-672 | LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA] | 5 | Current NDC, Legacy NDC, 3 package rows | 20230301_3d87d9a4-860a-4ea7-a993-0f4adf1789da.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 |
|---|
| 68462-672-91 | 68462067291 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68462-672-95 | 68462067295 | 3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 1 KIT in 1 BLISTER PACK | 3 pouch | 2015-06-12 | 0000-00-00 | No | No | Current |