Orfadin
- Product NDC
- 66658-120
- 11-digit product format
- 666580120
- Labeler code
- 66658
- Product ID
- 66658-120_f9c6cef5-fb71-4cb0-9793-5c23ac04572e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitisinone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- SWEDISH ORPHAN BIOVITRUM AB (PUBL)
- Application
- NDA021232
- Marketing category
- NDA
- Marketing start
- 2016-07-01
- 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
- Orfadin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITISINONE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K5BN214699 |
| Rxcui | 351173, 351174, 351175, 352119, 352120, 352121, 1798999, 1799001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66658-120-60 | Orfadin | 1 in 1 CARTON | CAPSULE | 1 | | 14 |
| 66658-120-60 | Orfadin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66658-120 | ORFADIN (NITISINONE) CAPSULE [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 14 | Current NDC, Legacy NDC, 2 package rows | 20220612_5d449b73-d503-4132-b978-d890491975df.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 |
|---|
| 66658-120-60 | 66658012060 | 1 BOTTLE, PLASTIC in 1 CARTON (66658-120-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC | 2016-07-01 | 0000-00-00 | No | No | Current |