PHEBURANE
- Product NDC
- 71770-210
- 11-digit product format
- 717700210
- Labeler code
- 71770
- Product ID
- 71770-210_4072f3df-e754-4c2e-be0c-af3c8edb9211
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium phenylbutyrate
- Dosage form
- PELLET
- Route
- ORAL
- Labeler
- Medunik USA
- Application
- NDA216513
- Marketing category
- NDA
- Marketing start
- 2022-09-14
- Substance
- SODIUM PHENYLBUTYRATE
- Active strength
- 483 mg/g
- Pharmacologic classes
- Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PHEBURANE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM PHENYLBUTYRATE | 483 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NT6K61736T |
| Rxcui | 2610128, 2610134 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71770-210-10 | PHEBURANE | 174 g in 1 BOTTLE | PELLET | 174 | | 6 |
| 71770-210-10 | PHEBURANE | 174 g in 1 BOTTLE | PELLET | 174 g | 483 mg in 1g | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71770-210 | PHEBURANE (SODIUM PHENYLBUTYRATE) PELLET PHEBURANE (SODIUM PHENYLBUTYRATE) KIT [MEDUNIK USA] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241222_d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9.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 |
|---|
| 71770-210-10 | 71770021010 | 174 g in 1 BOTTLE (71770-210-10) | 174 g | 2022-09-14 | 0000-00-00 | No | No | Current |