Budesonide Delayed-release Capsules

SPL v8

SPL

SPL Set ID d645a346-c99b-4de7-9bca-69e73266d6b4

Route

ORAL

Published

Effective Date 2025-02-12

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Budesonide (3 mg)

Inactive Ingredients

Acetyltributyl Citrate Alcohol Ammonia Butyl Alcohol Dimethicone Ethylcelluloses Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Gelatin Isopropyl Alcohol Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Potassium Hydroxide Propylene Glycol Shellac Sodium Lauryl Sulfate Sucrose Talc Titanium Dioxide Triethyl Citrate Water

Identifiers & Packaging

Pill Appearance

Imprint: 720 Shape: capsule Color: orange Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2017-06-08

Description

NDC 70771-1075-1 in bottle of 100 capsules Budesonide Delayed-Release Capsules 3 mg 100 capsules Rx only

Medication Information

Description

NDC 70771-1075-1 in bottle of 100 capsules Budesonide Delayed-Release Capsules 3 mg 100 capsules Rx only

Package Label.principal Display Panel

NDC 70771-1075-1 in bottle of 100 capsules

Budesonide Delayed-Release Capsules 3 mg

100 capsules

Rx only

Structured Label Content

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

NDC 70771-1075-1 in bottle of 100 capsules

Budesonide Delayed-Release Capsules 3 mg

100 capsules

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1075-1 in bottle of 100 capsules Budesonide Delayed-Release Capsules 3 mg 100 capsules Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:45:41.941630 · Updated: 2026-03-14T22:23:02.503835