Levonorgestrel and Ethinyl Estradiol
- Product NDC
- 68180-843
- 11-digit product format
- 681800843
- Labeler code
- 68180
- Product ID
- 68180-843_21d90467-0daa-44ee-8cad-f8a684cfa569
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA091440
- Marketing category
- ANDA
- Marketing start
- 2012-10-24
- 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 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 |
|---|
| 68180-843-13 | Levonorgestrel and Ethinyl Estradiol | 3 in 1 CARTON | KIT | 3 | | 18 |
| 68180-843-13 | Levonorgestrel and Ethinyl Estradiol | 1 in 1 BLISTER PACK | KIT | 1 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-843 | LEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250108_58e85e02-93e7-42ba-b8f5-a36290c68423.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 |
|---|
| 68180-843-13 | 68180084313 | 3 BLISTER PACK in 1 CARTON (68180-843-13) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2012-10-24 | 0000-00-00 | No | No | Current |