NDC 68475-001

Sodium Phenylacetate and sodium benzoate

Sodium Phenylacetate And Sodium Benzoate

Sodium Phenylacetate and sodium benzoate is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Navinta Llc. The primary component is Sodium Phenylacetate; Sodium Benzoate.

Product ID68475-001_2ff6227b-08a2-471e-8b3c-b1ec47b43248
NDC68475-001
Product TypeHuman Prescription Drug
Proprietary NameSodium Phenylacetate and sodium benzoate
Generic NameSodium Phenylacetate And Sodium Benzoate
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-03-04
Marketing CategoryANDA / ANDA
Application NumberANDA205880
Labeler NameNavinta LLC
Substance NameSODIUM PHENYLACETATE; SODIUM BENZOATE
Active Ingredient Strength100 mg/mL; mg/mL
Pharm ClassesAmmonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68475-001-50

1 VIAL in 1 CARTON (68475-001-50) > 50 mL in 1 VIAL
Marketing Start Date2021-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68475-001-50 [68475000150]

Sodium Phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA205880
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-07

Drug Details

NDC Crossover Matching brand name "Sodium Phenylacetate and sodium benzoate" or generic name "Sodium Phenylacetate And Sodium Benzoate"

NDCBrand NameGeneric Name
13811-705SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoate
67457-844Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium Benzoate
68382-396SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoate
68475-001Sodium Phenylacetate and sodium benzoateSodium Phenylacetate and sodium benzoate
68682-001Sodium Phenylacetate and Sodium Benzoatesodium phenylacetate and sodium benzoate
69784-810SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoate
69784-811SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoate
70511-101SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoate
70511-102Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium Benzoate
70556-100SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoate
72266-236Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium Benzoate
72266-247Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium Benzoate
0187-0010Ammonulsodium phenylacetate and sodium benzoate
62592-720Ammonulsodium phenylacetate and sodium benzoate
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