HARLIKU
- Product NDC
- 70709-112
- 11-digit product format
- 707090112
- Labeler code
- 70709
- Product ID
- 70709-112_2d883e57-720f-494e-be8f-db592ba0aa32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitisinone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cycle Pharmaceuticals Ltd.
- Application
- NDA209449
- Marketing category
- NDA
- Marketing start
- 2025-07-21
- Substance
- NITISINONE
- Active strength
- 2 mg/1
- Pharmacologic classes
- 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HARLIKU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITISINONE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K5BN214699 |
| Rxcui | 1941474, 2719722 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70709-112-60 | HARLIKU | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 70709-112-60 | HARLIKU | 1 in 1 CARTON | TABLET | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70709-112-60 | 70709011260 | 1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60) / 60 TABLET in 1 BOTTLE, PLASTIC | 2025-07-21 | No | No | Historical |