SODIUM PHENYLACETATE and SODIUM BENZOATE
- Product NDC
- 13811-705
- 11-digit product format
- 138110705
- Labeler code
- 13811
- Product ID
- 13811-705_ce2daf65-377d-11e1-e053-2a95a90a6f0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium phenylacetate and sodium benzoate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Trigen Laboratories, LLC
- Application
- ANDA207096
- Marketing category
- ANDA
- Marketing start
- 2016-02-24
- Marketing end
- 2022-06-30
- 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
- 0000-00-00
- 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 |
|---|
| 13811-705-50 | 13811070550 | 1 VIAL, SINGLE-DOSE in 1 CARTON (13811-705-50) > 50 mL in 1 VIAL, SINGLE-DOSE | 2016-02-26 | 2022-06-30 | No | No | Current |