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Indomethacin - Medication Information

Product NDC Code 70771-1203
Drug Name

Indomethacin

Type Generic
Pharm Class Anti-Inflammatory Agents,
Non-Steroidal [CS],
Cyclooxygenase Inhibitors [MoA],
Nonsteroidal Anti-inflammatory Drug [EPC]
Active Ingredients
Indomethacin 75 mg/1
Route ORAL
Dosage Form CAPSULE, EXTENDED RELEASE
RxCUI drug identifier 310992
Application Number ANDA202711
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1203-0 1000 capsule, extended release in 1 bottle (70771-1203-0)
70771-1203-1 100 capsule, extended release in 1 bottle (70771-1203-1)
70771-1203-4 10 blister pack in 1 carton (70771-1203-4) / 10 capsule, extended release in 1 blister pack (70771-1203-2)
70771-1203-5 500 capsule, extended release in 1 bottle (70771-1203-5)
70771-1203-6 60 capsule, extended release in 1 bottle (70771-1203-6)
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Spl product data elements

Usually a list of ingredients in a drug product.
indomethacin indomethacin INDOMETHACIN INDOMETHACIN STARCH, CORN FD&C BLUE NO. 1 HYPROMELLOSES LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE GELATIN SHELLAC PROPYLENE GLYCOL AMMONIA FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE WATER DARK BLUE DARK BLUE CAPSULE ZA;79;75mg

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1203-6 Indomethacin Extended-release Capsules, 75 mg 60 Capsules Rx only label

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API