Ammonul
- Product NDC
- 0187-0010
- 11-digit product format
- 001870010
- Labeler code
- 0187
- Product ID
- 0187-0010_de82ac73-cc5f-4e5d-8dfb-9cb98c625bdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium phenylacetate and sodium benzoate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Bausch Health US LLC
- Application
- NDA020645
- Marketing category
- NDA
- Marketing start
- 2005-02-17
- 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
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| sodium benzoate | ACTIVE INGREDIENT | OJ245FE5EU | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| sodium phenylacetate | ACTIVE INGREDIENT | 48N6U1781G | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| benzoic acid | ACTIVE MOIETY | 8SKN0B0MIM | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| phenylacetic acid | ACTIVE MOIETY | ER5I1W795A | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-0010 | AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [BAUSCH HEALTH US LLC] | 12 | Legacy NDC | 20250410_e00521d3-84f1-4586-b4a8-9dc17ffffcb1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-0010-50 | 00187001050 | 1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) > 50 mL in 1 VIAL, SINGLE-USE | 2005-02-17 | 0000-00-00 | No | No | Current |