FDA.reportPublic FDA data

NITYR

Product NDC
70709-002
11-digit product format
707090002
Labeler code
70709
Product ID
70709-002_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
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
NITYR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITISINONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BN214699
Rxcui1941464, 1941470, 1941471, 1941473, 1941474, 1941476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30289e20-d00d-4455-8aae-af8add8f10eeProduct name420240529
5b3e65b0-2e25-4346-b6a5-74172e0cd130Product name120170824
689eee6a-c9bd-41ef-86ac-b494143eb282Product name220160804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70709-002-60NITYR1 in 1 CARTONTABLET113
70709-002-60NITYR60 in 1 BOTTLE, PLASTICTABLET6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70709-002-60EA - Each70709-002caf5dda5-75a7-4403-b077-57de493bced712017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70709-002NITYR (NITISINONE) TABLET [CYCLE PHARMACEUTICALS LTD.]12Current NDC, Legacy NDC, 2 package rows20240601_00fd1905-27e4-420e-8dc5-a69e4ddc1526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1941464nitisinone 10 MG Oral TabletPSN00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941474nitisinone 2 MG Oral TabletPSN00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941471nitisinone 5 MG Oral TabletPSN00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941470NITYR 10 MG Oral TabletPSN00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941476NITYR 2 MG Oral TabletPSN00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941473NITYR 5 MG Oral TabletPSN00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941470nitisinone 10 MG Oral Tablet [Nityr]SBD00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941476nitisinone 2 MG Oral Tablet [Nityr]SBD00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941473nitisinone 5 MG Oral Tablet [Nityr]SBD00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941464nitisinone 10 MG Oral TabletSCD00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941474nitisinone 2 MG Oral TabletSCD00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941471nitisinone 5 MG Oral TabletSCD00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941470Nityr 10 MG Oral TabletSY00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941476Nityr 2 MG Oral TabletSY00fd1905-27e4-420e-8dc5-a69e4ddc152613
1941473Nityr 5 MG Oral TabletSY00fd1905-27e4-420e-8dc5-a69e4ddc152613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70709-002-60707090002601 BOTTLE, PLASTIC in 1 CARTON (70709-002-60) / 60 TABLET in 1 BOTTLE, PLASTIC2017-07-260000-00-00NoNoCurrent