ICOTYDE
- Product NDC
- 57894-201
- 11-digit product format
- 578940201
- Labeler code
- 57894
- Product ID
- 57894-201_4d42efb1-d399-2a77-e063-6294a90af3cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icotrokinra
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Janssen Biotech, Inc.
- Application
- NDA220149
- Marketing category
- NDA
- Marketing start
- 2026-03-17
- Substance
- ICOTROKINRA
- Active strength
- 200 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ICOTYDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICOTROKINRA | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MUW8FP7HNZ |
| Rxcui | 2739036, 2739042 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-201-01 | ICOTYDE | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 2 |
| 57894-201-07 | ICOTYDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 57894-201-30 | ICOTYDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 57894-201-30 | ICOTYDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57894-201-01 | 57894020101 | 7 in 1 BLISTER PACK | | | | | Historical |
| 57894-201-07 | 57894020107 | 1 BLISTER PACK in 1 CARTON (57894-201-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK (57894-201-01) | 1 blister pack | 2026-03-17 | No | No | Current |
| 57894-201-30 | 57894020130 | 1 BOTTLE in 1 CARTON (57894-201-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2026-03-17 | No | No | Current |