Does Indomethacin have a boxed warning?

The label we quote has no boxed warning, but 69 of 74 FDA labels for this medicine do. Check the label of your own product.

Is there a shortage of Indomethacin?

No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).

Has Indomethacin been recalled?

FDA enforcement reports list 7 recalls of products of this medicine; the newest started May 15, 2025 (Class II). A recall usually concerns specific lots, not every product.

Who makes Indomethacin?

32 companies list prescription products of Indomethacin in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and PD-Rx Pharmaceuticals, Inc..

Indomethacin (Indocin): uses, warnings, recalls

Quick answers

What is Indomethacin used for?: The FDA-approved label (Indomethacin, Fresenius Kabi USA, LLC, January 19, 2026) says: “Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Indomethacin have a boxed warning?: The label we quote has no boxed warning, but 69 of 74 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Indomethacin?: No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Indomethacin been recalled?: FDA enforcement reports list 7 recalls of products of this medicine; the newest started May 15, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Indomethacin?: 32 companies list prescription products of Indomethacin in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and PD-Rx Pharmaceuticals, Inc..

What Indomethacin is used for

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

Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. …

— FDA label: Indomethacin, Fresenius Kabi USA, LLC, effective January 19, 2026. Read the full label on DailyMed →

The FDA has 74 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.

69 of 74 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage forms	Capsule · Capsule, extended release · Suppository · Injection, powder, lyophilized, for solution · Suspension
Route	Oral · Rectal · Intravenous
Prescription products	84 in the FDA NDC Directory
Brand names	Indocin

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Indomethacin, by strength and form
Strength and form	Generic or brand	Pharmacies pay
indomethacin 25 mg capsule	Generic	$0.1004 per capsule
indomethacin 50 mg capsule	Generic	$0.1243 per capsule
indomethacin 75 mg capsule, extended release	Generic	$0.2188 per capsule

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

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.

Bryant Ranch Prepack15 products
A-S Medication Solutions7 products
PD-Rx Pharmaceuticals, Inc.6 products
Proficient Rx LP5 products
Camber Pharmaceuticals, Inc.4 products
Northwind Health Company, LLC4 products
NuCare Pharmaceuticals, Inc.4 products
Direct_Rx3 products
Fresenius Kabi USA, LLC3 products
Preferred Pharmaceuticals Inc.3 products
Remedyrepack Inc.3 products
Glenmark Pharmaceuticals Inc., USA3 products
XLCare Pharmaceuticals, Inc.2 products
Asclemed USA, Inc.2 products
AvPAK2 products
Chartwell RX, LLC2 products
Zydus Pharmaceuticals USA Inc.2 products
St. Mary's Medical Park Pharmacy2 products
Zyla Life Sciences US Inc.1 product
KVK-Tech, Inc.1 product
Coupler LLC1 product
ANI Pharmaceuticals, Inc.1 product
NorthStar RxLLC1 product
Hikma Pharmaceuticals USA Inc.1 product
Sportpharm LLC1 product
Zydus Lifesciences Limited1 product
Amneal Pharmaceuticals LLC1 product
RedPharm Drug, Inc.1 product
American Health Packaging1 product
Zyla Life Sciences US LLC1 product
Amneal Pharmaceuticals NY LLC1 product
Advanced Rx Pharmacy of Tennessee, LLC1 product

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
Application	Sponsor	Approved	Later changes approved
NDA018332 INDOCIN	Cosette	October 10, 1985	28, latest November 21, 2024 2024: Labeling · 2021: Labeling · 2019: Labeling
NDA018829 INDOMETHACIN	Chartwell Molecules	August 6, 1984	17, latest November 21, 2024 2024: Labeling · 2021: Labeling · 2016: Labeling
NDA022536 INDOMETHACIN	Fresenius Kabi USA	March 17, 2010	2, latest December 21, 2021 2021: Labeling · 2015: Manufacturing (CMC)

Generic approvals (13)

ANDA070651Chartwell Molecules · March 5, 1986
ANDA073314Cosette · August 31, 1992
ANDA079175Avanthi Inc · March 6, 2009
ANDA091549Amneal Pharms · December 1, 2010
ANDA091276Glenmark Pharms Ltd · December 22, 2010
ANDA091240Hetero Labs Ltd III · April 12, 2011
ANDA201807Hetero Labs Ltd III · September 28, 2012
ANDA203501Glenmark Pharms Ltd · June 22, 2017
ANDA216184Zydus Lifesciences · August 2, 2023
ANDA217883Novitium Pharma · January 12, 2024
ANDA215899Hikma · November 19, 2024
ANDA215399Amneal · February 24, 2025
ANDA216905Annora Pharma · July 3, 2025

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

May 15, 2025 · Class II · Ongoing · D-0454-2025

cGMP deviations

Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (bl — Amerisource Health Services LLC
May 9, 2025 · Class II · Ongoing · D-0445-2025

cGMP deviations

Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01. — KVK Tech, Inc.
March 13, 2025 · Class II · Ongoing · D-0329-2025

CGMP Deviations

Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ — Glenmark Pharmaceuticals Inc., USA
July 31, 2024 · Class II · Ongoing · D-0643-2024

Failed Dissolution Specifications: below specification results

Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phas — Glenmark Pharmaceuticals Inc., USA
November 7, 2023 · Class II · Ongoing · D-0123-2024

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 684 — Glenmark Pharmaceuticals Inc., USA
July 18, 2018 · Class II · Terminated · D-1019-2018

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543- — Hetero Labs, Ltd. - Unit III
March 19, 2018 · Class III · Terminated · D-0606-2018

Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC — Glenmark Pharmaceuticals Inc., USA

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)	197817, 197818, 197819, 206969, 206971, 310991, 310992, 346508
SPL set ID of the quoted label	ec482425-358c-4500-8f5d-79c1379c1fa8
FDA labels (SPL)	74
FDA applications	NDA018332, NDA018829, NDA022536, 13 ANDA
Active ingredients (FDA)	INDOMETHACIN

Sources

FDA-approved label on DailyMed (National Library of Medicine) — Indomethacin, Fresenius Kabi USA, LLC, effective January 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
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 →

Report an error → · Information for medicine makers

Indomethacin

Official FDA data, not advice

At a glance