Daysee
- Product NDC
- 68180-846
- 11-digit product format
- 681800846
- Labeler code
- 68180
- Product ID
- 68180-846_9d52f9d2-f66b-4457-8cb7-c48a6e7d076f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVONORGESTREL AND ETHINYL ESTRADIOL
- Dosage form
- KIT
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA091467
- Marketing category
- ANDA
- Marketing start
- 2013-04-10
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Daysee
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238019, 248310, 749761, 1423123 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-846-13 | Daysee | 1 in 1 POUCH | KIT | 1 | | 17 |
| 68180-846-13 | Daysee | 2 in 1 CARTON | KIT | 2 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-846 | DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250515_a9861412-4e54-4984-b14c-a1dd91d5c946.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 |
|---|
| 68180-846-13 | 68180084613 | 2 POUCH in 1 CARTON (68180-846-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 2 pouch | 2013-04-10 | 0000-00-00 | No | No | Current |