Indomethacin Suppositories, For Rectal Use

SPL v1

SPL

SPL Set ID c6ca86fb-df23-42c1-9d29-f15312faf60c

Route

RECTAL

Published

Effective Date 2023-08-03

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Indomethacin (50 mg)

Inactive Ingredients

Hard Fat

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2023-08-03

Description

NDC 70771-1766-7 Indomethacin Suppositories USP, 50 mg 30 rectal suppositories Rx only

Medication Information

Description

NDC 70771-1766-7 Indomethacin Suppositories USP, 50 mg 30 rectal suppositories Rx only

Package Label.principal Display Panel

NDC 70771-1766-7

Indomethacin Suppositories USP, 50 mg

30 rectal suppositories

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1766-7

Indomethacin Suppositories USP, 50 mg

30 rectal suppositories

Rx only

Advanced Ingredient Data

[{"name": "INDOMETHACIN", "unii": "XXE1CET956", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HARD FAT", "unii": "8334LX7S21", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1766-7 Indomethacin Suppositories USP, 50 mg 30 rectal suppositories Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:38:43.587619 · Updated: 2026-03-14T21:55:34.492759