Sodium Phenylacetate and Sodium Benzoate
- Product NDC
- 67457-844
- 11-digit product format
- 674570844
- Labeler code
- 67457
- Product ID
- 67457-844_80c174b3-5287-4fb5-b4c1-e1d5208c249e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Phenylacetate and Sodium Benzoate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA208521
- Marketing category
- ANDA
- Marketing start
- 2017-05-23
- Marketing end
- 0000-00-00
- Substance
- SODIUM PHENYLACETATE; SODIUM BENZOATE
- Active strength
- 100 mg/mL; mg/mL
- Pharmacologic classes
- Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-844-50 | 67457084450 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-844-50) > 50 mL in 1 VIAL, SINGLE-DOSE | 2017-05-23 | 0000-00-00 | No | No | Current |