Erlotinib Tablets

SPL v3

SPL

SPL Set ID daaa1329-3a3f-439c-b13d-b301daa234d4

Route

ORAL

Published

Effective Date 2022-10-03

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Erlotinib (25 mg)

Inactive Ingredients

Crospovidone (120 .mu.m) Hypromellose 2910 (6 Mpa.s) Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Polyethylene Glycol 4000 Silicon Dioxide Sodium Lauryl Sulfate Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 915 Shape: round Color: white Size: 6 mm Size: 9 mm Size: 11 mm Score: 1

Marketing Status

ANDA Active Since 2020-04-30

Description

Erlotinib Tablets, 25 mg 30 tablets NDC 70771-1521-3 Rx only Erlotinib Tablets, 100 mg 30 tablets NDC 70771-1522-3 Rx only Erlotinib Tablets, 150 mg 30 tablets NDC 70771-1523-3 Rx only

Medication Information

Description

Erlotinib Tablets, 25 mg 30 tablets NDC 70771-1521-3 Rx only Erlotinib Tablets, 100 mg 30 tablets NDC 70771-1522-3 Rx only Erlotinib Tablets, 150 mg 30 tablets NDC 70771-1523-3 Rx only

Package Label.principal Display Panel

Erlotinib Tablets, 25 mg

30 tablets

NDC 70771-1521-3

Rx only

Erlotinib Tablets, 100 mg

30 tablets

NDC 70771-1522-3

Rx only

Erlotinib Tablets, 150 mg

30 tablets

NDC 70771-1523-3

Rx only

Structured Label Content

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

Erlotinib Tablets, 25 mg

30 tablets

NDC 70771-1521-3

Rx only

Erlotinib Tablets, 100 mg

30 tablets

NDC 70771-1522-3

Rx only

Erlotinib Tablets, 150 mg

30 tablets

NDC 70771-1523-3

Rx only

Advanced Ingredient Data

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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "Erlotinib Tablets, 25 mg 30 tablets NDC 70771-1521-3 Rx only Erlotinib Tablets, 100 mg 30 tablets NDC 70771-1522-3 Rx only Erlotinib Tablets, 150 mg 30 tablets NDC 70771-1523-3 Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:59.013093 · Updated: 2026-03-14T22:18:18.443233