Nitisinone
- Product NDC
- 0254-3022
- 11-digit product format
- 002543022
- Labeler code
- 0254
- Product ID
- 0254-3022_8d22274c-76b2-4da0-85e0-c0fc61c7db0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitisinone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA211041
- Marketing category
- ANDA
- Marketing start
- 2019-10-04
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0254-3022-02 | Nitisinone | 1 in 1 CARTON | CAPSULE | 1 | | 7 |
| 0254-3022-02 | Nitisinone | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-3022 | NITISINONE CAPSULE [ENDO USA, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250406_437868f5-1c9e-4b0f-8a03-77df8ac0900d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0254-3022-02 | 00254302202 | 1 BOTTLE in 1 CARTON (0254-3022-02) / 60 CAPSULE in 1 BOTTLE | 1 bottle | 2019-10-04 | 0000-00-00 | No | No | Current |