PHEBURANE
- Product NDC
- 71770-200
- 11-digit product format
- 717700200
- Labeler code
- 71770
- Product ID
- 71770-200_4072f3df-e754-4c2e-be0c-af3c8edb9211
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium phenylbutyrate
- Dosage form
- KIT
- Labeler
- Medunik USA
- Application
- NDA216513
- Marketing category
- NDA
- Marketing start
- 2022-08-26
- 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
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 |
|---|
| 71770-200-10 | PHEBURANE | 1 in 1 CARTON | KIT | 1 | | 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 |
|---|
| 71770-200 | PHEBURANE (SODIUM PHENYLBUTYRATE) PELLET PHEBURANE (SODIUM PHENYLBUTYRATE) KIT [MEDUNIK USA] | 5 | Current NDC, Legacy NDC, 2 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 |
|---|
| 71770-200-10 | 71770020010 | 1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10) | 1 kit | 2022-08-26 | 0000-00-00 | No | No | Current |
| 71770-210-10 | 71770021010 | 174 g in 1 BOTTLE | 174 g | | | | | Historical |