FDA.reportPublic FDA data

ORFADIN

Product NDC
66658-204
11-digit product format
666580204
Labeler code
66658
Product ID
66658-204_463bdca4-b840-6f9f-e063-6294a90ab3b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitisinone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Swedish Orphan Biovitrum AB (publ)
Application
NDA206356
Marketing category
NDA
Marketing start
2016-06-01
Substance
NITISINONE
Active strength
4 mg/mL
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
ORFADIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITISINONE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BN214699
Rxcui1790310, 1790317

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30289e20-d00d-4455-8aae-af8add8f10eeProduct name420240529
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5b3e65b0-2e25-4346-b6a5-74172e0cd130Product name120170824
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
689eee6a-c9bd-41ef-86ac-b494143eb282Product name220160804

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66658-204-902021-07-28C16284748780-1c7ccaba7-161a-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN ® (nitisinone) capsules, for oral use ORFADIN ® (nitisinone) oral suspension Initial U.S. Approval: 2002
66658-204-902021-07-23C16284748780-1c7ccaba7-161a-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN ® (nitisinone) capsules, for oral use ORFADIN ® (nitisinone) oral suspension Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66658-204-90ORFADIN90 mL in 1 BOTTLE, GLASSSUSPENSION9012
66658-204-90ORFADIN1 in 1 CARTONSUSPENSION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66658-204-90ML - Milliliter66658-204dc1f2196-bfdb-4e71-b745-67474384612d12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66658-204ORFADIN (NITISINONE) SUSPENSION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]11Current NDC, Legacy NDC, 2 package rows20220706_00307f42-748d-4227-8c6f-ed5f0a89ae0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790310nitisinone 4 MG in 1 mL Oral SuspensionPSN00307f42-748d-4227-8c6f-ed5f0a89ae0a12
1790317Orfadin 4 MG in 1 mL Oral SuspensionPSN00307f42-748d-4227-8c6f-ed5f0a89ae0a12
1790317nitisinone 4 MG/ML Oral Suspension [Orfadin]SBD00307f42-748d-4227-8c6f-ed5f0a89ae0a12
1790310nitisinone 4 MG/ML Oral SuspensionSCD00307f42-748d-4227-8c6f-ed5f0a89ae0a12
1790310nitisinone 4 MG per 1 ML Oral SuspensionSY00307f42-748d-4227-8c6f-ed5f0a89ae0a12
1790317Orfadin 4 MG per 1 ML Oral SuspensionSY00307f42-748d-4227-8c6f-ed5f0a89ae0a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66658-204-90666580204901 BOTTLE, GLASS in 1 CARTON (66658-204-90) / 90 mL in 1 BOTTLE, GLASS2016-06-010000-00-00NoNoCurrent