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Prescription medicine · generic available

Ascorbic acid

Drug class: Vitamin C

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Ascorbic acid used for?
The FDA-approved label (Ascor, McGuff Pharmaceuticals, Inc., May 29, 2026) says: “1. INDICATIONS AND USAGE ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ascorbic acid have a boxed warning?
No. None of the 3 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Ascorbic acid?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ascorbic acid been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Ascorbic acid?
5 companies list prescription products of Ascorbic acid in the FDA NDC Directory, including Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc. and Renova Pharmaceuticals LLC.

What Ascorbic acid is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

1. INDICATIONS AND USAGE ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. …

— FDA label: Ascor, McGuff Pharmaceuticals, Inc., effective May 29, 2026. Read the full label on DailyMed →

The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 3 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection
RouteIntravenous
Prescription products9 in the FDA NDC Directory
Brand namesAscor

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA209112
ASCOR
McguffOctober 2, 2017 3, latest January 17, 2024
2024: Manufacturing (CMC) · 2023: Manufacturing (CMC) · 2022: Labeling

Generic approvals (3)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)308395, 2002739
SPL set ID of the quoted label388aad52-fc01-4784-9791-1dbc80c69306
FDA labels (SPL)3
FDA applicationsNDA209112, 3 ANDA
Active ingredients (FDA)ASCORBIC ACID

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Ascor, McGuff Pharmaceuticals, Inc., effective May 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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