Miudella
- Product NDC
- 82686-300
- 11-digit product format
- 826860300
- Labeler code
- 82686
- Product ID
- 82686-300_372773b6-fbed-c74b-e063-6294a90a7bf2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Copper
- Dosage form
- INTRAUTERINE DEVICE
- Route
- INTRAUTERINE
- Labeler
- Sebela Women's Health Inc.
- Application
- NDA218201
- Marketing category
- NDA
- Marketing start
- 2025-10-01
- Substance
- COPPER
- Active strength
- 175 mm/1
- Pharmacologic classes
- Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Miudella
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COPPER | 175 mm/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 789U1901C5 |
| Rxcui | 2724423, 2724428 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82686-300-01 | Miudella | 1 in 1 BOX, UNIT-DOSE | INTRAUTERINE DEVICE | 1 | | 5 |
| 82686-300-01 | Miudella | 1 in 1 TRAY | INTRAUTERINE DEVICE | 1 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82686-300-01 | 82686030001 | 1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY | 1 tray | 2025-10-01 | No | No | Historical |