Nitisinone
- Product NDC
- 71863-121
- 11-digit product format
- 718630121
- Labeler code
- 71863
- Product ID
- 71863-121_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
- 10 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| Ingredient | Strength |
|---|
| NITISINONE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K5BN214699 |
| Rxcui | 351173, 351174, 351175, 1798999 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71863-121-60 | Nitisinone | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
| 71863-121-60 | Nitisinone | 1 in 1 CARTON | CAPSULE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71863-121 | NITISINONE CAPSULE [ETON PHARMACEUTICALS, INC.] | 4 | Current NDC, 2 package rows | 20241207_dc5e4875-fcd7-408c-88c9-4a715f4384b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71863-121-60 | 71863012160 | 1 BOTTLE in 1 CARTON (71863-121-60) / 60 CAPSULE in 1 BOTTLE | 1 bottle | 2024-01-15 | No | No | Current |