FDA.reportPublic FDA data

Nitisinone

Product NDC
71863-122
11-digit product format
718630122
Labeler code
71863
Product ID
71863-122_42c7c79b-1aa1-12bc-e063-6394a90a5ff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitisinone
Dosage form
CAPSULE
Route
ORAL
Labeler
Eton Pharmaceuticals, Inc.
Application
ANDA216201
Marketing category
ANDA
Marketing start
2024-01-15
Substance
NITISINONE
Active strength
20 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
Nitisinone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITISINONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BN214699
Rxcui351173, 351174, 351175, 1798999

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
71863-122-60Nitisinone1 in 1 CARTONCAPSULE15
71863-122-60Nitisinone60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71863-122-60EA - Each71863-122c3118dfb-d9c6-4604-ba26-9fd4386903e812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71863-122NITISINONE CAPSULE [ETON PHARMACEUTICALS, INC.]4Current NDC, 2 package rows20241207_dc5e4875-fcd7-408c-88c9-4a715f4384b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351175nitisinone 10 MG Oral CapsulePSNdc5e4875-fcd7-408c-88c9-4a715f4384b65
351173nitisinone 2 MG Oral CapsulePSNdc5e4875-fcd7-408c-88c9-4a715f4384b65
1798999nitisinone 20 MG Oral CapsulePSNdc5e4875-fcd7-408c-88c9-4a715f4384b65
351174nitisinone 5 MG Oral CapsulePSNdc5e4875-fcd7-408c-88c9-4a715f4384b65
351175nitisinone 10 MG Oral CapsuleSCDdc5e4875-fcd7-408c-88c9-4a715f4384b65
351173nitisinone 2 MG Oral CapsuleSCDdc5e4875-fcd7-408c-88c9-4a715f4384b65
1798999nitisinone 20 MG Oral CapsuleSCDdc5e4875-fcd7-408c-88c9-4a715f4384b65
351174nitisinone 5 MG Oral CapsuleSCDdc5e4875-fcd7-408c-88c9-4a715f4384b65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71863-122-60718630122601 BOTTLE in 1 CARTON (71863-122-60) / 60 CAPSULE in 1 BOTTLE1 bottle2024-01-15NoNoCurrent