SODIUM PHENYLACETATE and SODIUM BENZOATE
- Product NDC
- 69784-811
- 11-digit product format
- 697840811
- Labeler code
- 69784
- Product ID
- 69784-811_f6bb9d57-63e4-43c6-a3c2-0aa979d1c603
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium phenylacetate and sodium benzoate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Woodward Pharma Services LLC
- Application
- ANDA207096
- Marketing category
- ANDA
- Marketing start
- 2021-12-15
- Marketing end
- 0000-00-00
- Substance
- SODIUM BENZOATE; SODIUM PHENYLACETATE
- Active strength
- 100 mg/mL; mg/mL
- Pharmacologic classes
- Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69784-811 | SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [WOODWARD PHARMA SERVICES LLC] | 3 | Legacy NDC | 20250114_23900799-5137-4084-99e3-98d13389e5fb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69784-811-01 | 69784081101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69784-811-01) > 50 mL in 1 VIAL, SINGLE-DOSE | 2021-12-15 | 0000-00-00 | No | No | Current |