NITYR
- Product NDC
- 70709-005
- 11-digit product format
- 707090005
- Labeler code
- 70709
- Product ID
- 70709-005_9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitisinone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cycle Pharmaceuticals Ltd.
- Application
- NDA209449
- Marketing category
- NDA
- Marketing start
- 2017-07-26
- Substance
- NITISINONE
- Active strength
- 5 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
- NITYR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITISINONE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K5BN214699 |
| Rxcui | 1941464, 1941470, 1941471, 1941473, 1941474, 1941476 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70709-005-60 | NITYR | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 13 |
| 70709-005-60 | NITYR | 1 in 1 CARTON | TABLET | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70709-005 | NITYR (NITISINONE) TABLET [CYCLE PHARMACEUTICALS LTD.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240601_00fd1905-27e4-420e-8dc5-a69e4ddc1526.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70709-005-60 | 70709000560 | 1 BOTTLE, PLASTIC in 1 CARTON (70709-005-60) / 60 TABLET in 1 BOTTLE, PLASTIC | 2017-07-26 | 0000-00-00 | No | No | Current |