sodium phenylbutyrate
- Product NDC
- 68462-853
- 11-digit product format
- 684620853
- Labeler code
- 68462
- Product ID
- 68462-853_060b5266-8881-4270-b62d-df8e49ecfd4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium phenylbutyrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA216462
- Marketing category
- ANDA
- Marketing start
- 2022-11-01
- Substance
- SODIUM PHENYLBUTYRATE
- Active strength
- 500 mg/1
- 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NT6K61736T |
| Rxcui | 199369 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-853-20 | sodium phenylbutyrate | 250 in 1 BOTTLE | TABLET | 250 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-853 | SODIUM PHENYLBUTYRATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240103_0c76d25b-abac-41a3-a547-4fa4796bf7a4.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 |
|---|
| 68462-853-20 | 68462085320 | 250 TABLET in 1 BOTTLE (68462-853-20) | 250 tablet | 2022-11-01 | 0000-00-00 | No | No | Current |