Prescription drug · NDA
Miudella (Copper) NDC 78206-210
Copper 175 mm/1 · Intrauterine device · Intrauterine · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-210-01 | 7820602100178206021001 | 1 TRAY in 1 BOX, UNIT-DOSE (78206-210-01) / 1 INTRAUTERINE DEVICE in 1 TRAYMarketed from Dec 1, 2025 |
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)
- Miudella
- Generic name (nonproprietary)
- copper
- Active ingredients
- Copper — 175 mm/1
- Dosage form
- Intrauterine device
- Route
- Intrauterine
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218201
- Marketing start
- Listing expires
- Other FDA classes
- Copper (Chemical structure)Decreased Embryonic Implantation (Physiologic effect)Decreased Sperm Motility (Physiologic effect)Inhibit Ovum Fertilization (Physiologic effect)
- Identifiers
- Product ID 78206-210_27f852b0-5824-49c5-ad60-ae271f23acd4SPL ID 27f852b0-5824-49c5-ad60-ae271f23acd4
- Pharmacologic class
- Copper-containing Intrauterine Device
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
N478206021001followed by a unit qualifier and the quantityPackage 78206-0210-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 78206-210
- What is NDC 78206-210?
- 78206-210 is the product NDC for Miudella (copper), Copper 175 mm/1 intrauterine device, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miudella (Copper).
- What is the active ingredient?
- Copper.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Miudella?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.