Roflumilast Tablets, For Oral Use

SPL v4

SPL

SPL Set ID e87287bd-eae3-46c3-9072-04800aeabf40

Route

ORAL

Published

Effective Date 2024-08-12

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Roflumilast (500 ug)

Inactive Ingredients

Cellulose, Microcrystalline Hydroxypropyl Cellulose, Low Substituted Lactose Monohydrate Magnesium Stearate Poloxamer 407 Silicon Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: T6 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2023-05-18

Description

NDC 70771-1674-3 Roflumilast Tablets, 500 mcg 30 tablets Rx only NDC 70771-1673-8 Roflumilast Tablets, 250 mcg Blister pack of 28 tablets Rx only

Medication Information

Description

NDC 70771-1674-3 Roflumilast Tablets, 500 mcg 30 tablets Rx only NDC 70771-1673-8 Roflumilast Tablets, 250 mcg Blister pack of 28 tablets Rx only

Package Label.principal Display Panel

NDC 70771-1674-3

Roflumilast Tablets, 500 mcg

30 tablets

Rx only

NDC 70771-1673-8

Roflumilast Tablets, 250 mcg

Blister pack of 28 tablets

Rx only

Structured Label Content

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

NDC 70771-1674-3

Roflumilast Tablets, 500 mcg

30 tablets

Rx only

NDC 70771-1673-8

Roflumilast Tablets, 250 mcg

Blister pack of 28 tablets

Rx only

Advanced Ingredient Data

[{"name": "ROFLUMILAST", "unii": "0P6C6ZOP5U", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED", "unii": "2165RE0K14", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROFLUMILAST", "unii": "0P6C6ZOP5U", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED", "unii": "2165RE0K14", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1674-3 Roflumilast Tablets, 500 mcg 30 tablets Rx only NDC 70771-1673-8 Roflumilast Tablets, 250 mcg Blister pack of 28 tablets Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:42:26.391926 · Updated: 2026-03-14T22:09:11.898870