Mirena
- Product NDC
- 50419-423
- 11-digit product format
- 504190423
- Labeler code
- 50419
- Product ID
- 50419-423_ab3e1924-b102-48c1-8188-a089524e9dd0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- INTRAUTERINE DEVICE
- Route
- INTRAUTERINE
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA021225
- Marketing category
- NDA
- Marketing start
- 2009-10-01
- Substance
- LEVONORGESTREL
- Active strength
- 52 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirena
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVONORGESTREL | 52 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5W7SIA7YZW |
| Rxcui | 804156, 807283 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50419-423-01 | Mirena | 1 in 1 CARTON | INTRAUTERINE DEVICE | 1 | | 20 |
| 50419-423-08 | Mirena | 1 in 1 CARTON | INTRAUTERINE DEVICE | 1 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50419-423 | MIRENA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240724_dcbd6aa2-b3fa-479a-a676-56ea742962fc.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 |
|---|
| 50419-423-01 | 50419042301 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01) | 1 intrauterine device | 2014-05-30 | 0000-00-00 | No | No | Current |
| 50419-423-08 | 50419042308 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-08) | 1 intrauterine device | 2016-12-08 | 0000-00-00 | No | No | Current |