Skyla
- Product NDC
- 50419-422
- 11-digit product format
- 504190422
- Labeler code
- 50419
- Product ID
- 50419-422_01b52e09-d273-4503-8589-a2bb64c1574c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- INTRAUTERINE DEVICE
- Route
- INTRAUTERINE
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA203159
- Marketing category
- NDA
- Marketing start
- 2013-01-11
- Substance
- LEVONORGESTREL
- Active strength
- 13.5 mg/1
- Pharmacologic classes
- 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
- Skyla
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVONORGESTREL | 13.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5W7SIA7YZW |
| Rxcui | 1366334, 1366339 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50419-422-01 | Skyla | 1 in 1 CARTON | INTRAUTERINE DEVICE | 1 | | 22 |
| 50419-422-08 | Skyla | 1 in 1 CARTON | INTRAUTERINE DEVICE | 1 | | 22 |
| 50419-422-71 | Skyla | 1 in 1 CARTON | INTRAUTERINE DEVICE | 1 | | 22 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50419-422 | SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 19 | Current NDC, Legacy NDC, 3 package rows | 20241207_9f44ff35-e052-49cd-a1c2-0bfd87d49309.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 |
|---|
| 50419-422-01 | 50419042201 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01) | 1 intrauterine device | 2013-01-11 | 0000-00-00 | No | No | Current |
| 50419-422-08 | 50419042208 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08) | 1 intrauterine device | 2013-01-11 | 0000-00-00 | No | No | Current |
| 50419-422-71 | 50419042271 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-71) | 1 intrauterine device | 2013-01-11 | 0000-00-00 | No | No | Current |