Modafinil Tablets Civ

SPL v6

SPL

SPL Set ID f39820fb-8248-4d42-854c-6fe2d9b92d36

Route

ORAL

Published

Effective Date 2024-08-16

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Modafinil (100 mg)

Inactive Ingredients

Cellulose, Microcrystalline Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Povidone Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 10;73 Shape: capsule Color: white Size: 13 mm Size: 16 mm Score: 2

Marketing Status

ANDA Active Since 2018-01-04

Description

NDC 70771-1051-3 Modafinil Tablets USP, 100 mg 30 Tablets Rx only NDC 70771-1052-3 Modafinil Tablets USP, 200 mg 30 Tablets Rx only

Medication Information

Description

NDC 70771-1051-3 Modafinil Tablets USP, 100 mg 30 Tablets Rx only NDC 70771-1052-3 Modafinil Tablets USP, 200 mg 30 Tablets Rx only

Package Label.principal Display Panel

NDC 70771-1051-3

Modafinil Tablets USP, 100 mg

30 Tablets

Rx only

NDC 70771-1052-3

Modafinil Tablets USP, 200 mg

30 Tablets

Rx only

Structured Label Content

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

NDC 70771-1051-3

Modafinil Tablets USP, 100 mg

30 Tablets

Rx only

NDC 70771-1052-3

Modafinil Tablets USP, 200 mg

30 Tablets

Rx only

Advanced Ingredient Data

[{"name": "MODAFINIL", "unii": "R3UK8X3U3D", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "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": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MODAFINIL", "unii": "R3UK8X3U3D", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "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": "POVIDONE", "unii": "FZ989GH94E", "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 70771-1051-3 Modafinil Tablets USP, 100 mg 30 Tablets Rx only NDC 70771-1052-3 Modafinil Tablets USP, 200 mg 30 Tablets Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:42:33.088106 · Updated: 2026-03-14T22:09:49.950257