General MedicationsINTRAVENOUSStandard

SODIUM BICARBONATE

Standard Dose

2.5MEQ/5ML (0.5MEQ/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview SODIUM BICARBONATE is listed in Drugs@FDA under application 206688 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM BICARBONATE Form and strength SOLUTION;INTRAVENOUS - 2.5MEQ/5ML (0.5MEQ/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-08-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview SODIUM BICARBONATE is listed in Drugs@FDA under application 206688 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM BICARBONATE Form and strength SOLUTION;INTRAVENOUS - 2.5MEQ/5ML (0.5MEQ/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-08-25 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.