Sodium Phenylbutyrate
- Product NDC
- 49884-006
- 11-digit product format
- 498840006
- Labeler code
- 49884
- Product ID
- 49884-006_583e7b91-8e00-4c38-a78f-d8948ea95a20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Phenylbutyrate
- Dosage form
- POWDER
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA203918
- Marketing category
- ANDA
- Marketing start
- 2016-08-31
- Substance
- SODIUM PHENYLBUTYRATE
- Active strength
- .94 g/g
- Pharmacologic classes
- Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium Phenylbutyrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM PHENYLBUTYRATE | .94 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NT6K61736T |
| Rxcui | 984105 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-006-04 | Sodium Phenylbutyrate | 250 g in 1 BOTTLE | POWDER | 250 | | 10 |
| 49884-006-04 | Sodium Phenylbutyrate | 1 in 1 CARTON | POWDER | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-006 | SODIUM PHENYLBUTYRATE POWDER [ENDO USA, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240820_639f5c7e-9f6d-47fb-a417-2be076176a78.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 |
|---|
| 49884-006-04 | 49884000604 | 1 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLE | 1 bottle | 2016-08-31 | 0000-00-00 | No | No | Current |