FDA Drug Regulatory Intelligence

Sodium Bicarbonate Injection shortage

Sodium Bicarbonate Injection is recorded by the U.S. Food and Drug Administration (FDA) with a shortage status of Current, covering 2 affected presentations across 1 strength, first posted 2017-03-01 and last updated 2026-08-18. 2 companies report it — Amphastar Pharmaceuticals, Inc. and Long Grove Pharmaceuticals LLC — across 2 source lines. The strengths listed are 84 mg/1 mL. 3 package NDCs are referenced, under 2 FDA application numbers and 1 substance identifier. The FDA files it under Endocrinology/Metabolism, Gastroenterology and Pediatric. Neither the FDA record nor RxNorm publishes a brand name for this product, so none is shown. Every line is reproduced below with its company, presentation, package NDC and the FDA's own availability text, so each can be checked individually. Confirm the live status at the official FDA shortage record before relying on it: this page is regulatory supply information only, it is not medical advice, it does not assess clinical impact, and it never suggests a substitute.

Regulatory snapshot

FDA shortage status Current
Since (first posted) 2017-03-01
Last updated 2026-08-18
Affected presentations 2
Strengths listed 1 (84 mg/1 mL)
Reporting manufacturers 2
Brand names None in FDA or RxNorm data
Generic name Sodium Bicarbonate Injection
Product form Injection
Therapeutic category Endocrinology/Metabolism, Gastroenterology, Pediatric
Package NDCs listed 3
openFDA source rows 2
Official source https://www.accessdata.fda.gov/scripts/drugshortages/

Affected presentations, companies and availability

The FDA publishes one line per reported package presentation and reporting company. All 2 line(s) behind this entry are reproduced below — company, presentation, strength, package NDC, status, the agency's availability text verbatim, and the date each line was last updated — so any single line can be checked against the official record without leaving this page. No line becomes a page of its own.

Reporting companyPresentationStrengthPackage NDCStatusAvailability (FDA text)Updated
Long Grove Pharmaceuticals LLC Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 81298-7620-3) 84 mg/1 mL 81298-7620-3 Current Available 2026-08-17
Amphastar Pharmaceuticals, Inc. Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 76329-3352-1) 84 mg/1 mL 76329-3352-1 Current Limited Availability 2026-08-18

FDA application number(s) recorded against the affected products: ANDA203449, ANDA216042. Substance identifier(s) (UNII): 8MDF5V39QO.

Reporting manufacturers (2)

Each company below filed at least one of the source lines above. The record counts shown are coverage-limited activity signals from the indexed datasets — never quality ratings.

CompanyLines filed hereIndexed recordsRecallsShortage entries
Amphastar Pharmaceuticals, Inc. 1 6 0 6
Long Grove Pharmaceuticals LLC 1 1 0 1

Reason recorded by the FDA

Reproduced verbatim from the FDA's shortage record as a regulatory data field — not restated, summarised or interpreted here.

Related shortages

Every link below comes from a relation in the FDA data itself — a shared substance identifier, a shared reporting company, or a shared FDA therapeutic category — ordered by the strength of that overlap. Nothing here is a popularity list or an editorial suggestion.

Reported by the same companies

Same FDA therapeutic category

How to interpret this shortage record

A drug-shortage entry means the FDA has logged a reported supply constraint for a product as part of its public shortage tracking. The status (Current) describes where the shortage sits in its lifecycle according to the agency's data. Because the FDA publishes one line per reported package and reporting company, this page consolidates 2 such lines into the single shortage they describe; each line remains listed below with its own company, presentation and availability text so it can be checked individually against the source. A shortage entry is an administrative supply signal — it does not describe the clinical role of the product, does not suggest any substitute, and does not indicate that any specific patient is affected. Read this entry as a pointer to the official FDA shortage listing and confirm the live status there before relying on it.

What an FDA shortage entry is

A drug-shortage entry of this kind is an administrative supply-status record that the FDA maintains and publishes for transparency and reference. It names the affected product, attributes the report to the companies shown above, and records a status marking where the shortage sits within the agency's public tracking lifecycle at the time it was ingested by this site. The FDA publishes one line per reported package presentation and reporting company, so this entry is assembled from 2 such lines rather than one page per line. The earliest initial posting date across them is 2017-03-01, and the latest update 2026-08-18. The FDA files this product under Endocrinology/Metabolism, Gastroenterology and Pediatric in its own therapeutic categorisation, which is reproduced here as a source field and carries no clinical meaning on this page. All values shown here are reproduced as regulatory data points from the official FDA drug-shortages dataset to help you find and verify the original entry. This page does not advise on therapeutic substitution, does not assess clinical impact, and is not a recommendation of any kind.

Why this page has one address

This page's address is derived from the shortage's own identity — the product name as the FDA publishes it, including the form in which it is supplied — and not from the entry's status, from the reporting company, or from the order in which the openFDA API happened to return its rows. That means the address stays the same when the status changes from current to resolved, when another company is added to the same shortage, or when a further package presentation is reported. Distinct product forms of the same molecule — an injection and an oral capsule, say — remain distinct pages, because the FDA tracks them as separate shortages. 12 earlier addresses for this entry redirect here permanently, so previously published links continue to resolve.

What this record does not mean

This shortage record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.

How to read this data

Where to go next

Source & provenance

Official source
https://www.accessdata.fda.gov/scripts/drugshortages/
Source dataset
openFDA Drug Shortages API
Publication date
2017-03-01
Ingested
2026-08-22
Record hash
6317cfef80d3ab0b

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.