Prescription drug · NDA
Mirena (levonorgestrel) NDC 50419-423
Levonorgestrel 52 mg/1 · Intrauterine device · Intrauterine · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-423-01 | 50419042301 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01)Marketed from May 30, 2014 | |
| 50419-423-08 | 50419042308 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-08)Marketed from Dec 8, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mirena
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 52 mg/1
- Dosage form
- Intrauterine device
- Route
- Intrauterine
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021225
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 50419-423_ab3e1924-b102-48c1-8188-a089524e9dd0SPL ID ab3e1924-b102-48c1-8188-a089524e9dd0SPL set ID dcbd6aa2-b3fa-479a-a676-56ea742962fcRxCUI 804156, 807283UNII 5W7SIA7YZW
- Pharmacologic class
- Progestin; Progestin-containing Intrauterine System
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450419042301followed by a unit qualifier and the quantityPackage 50419-0423-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Mirena is a progestin-containing intrauterine system (IUS) indicated for: • Prevention of pregnancy for up to 8 years ( 1.1 ) • Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years. ( 1.2 ) 1.1 Contraception Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. 1.2 Heavy Menstrual Bleeding Mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding …
Excerpt only. Read the full label for complete information.