DailyMed - DailyMed Details

SPL v4

SPL

SPL Set ID 82c0ed15-9132-657d-e053-2991aa0ae90a

Route

ORAL

Published

Effective Date 2018-08-20

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Gabapentin (300 mg)

Inactive Ingredients

Lactose Monohydrate Starch, Corn Talc Gelatin Titanium Dioxide Ferric Oxide Yellow Propylene Glycol Shellac

Identifiers & Packaging

Pill Appearance

Imprint: 104 Shape: capsule Color: yellow Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2015-12-30

Description

100 mg Capsules (White/White colored, size 3 hard gelatin capsules with 103 printed on body of capsules containing white to off white granular powder) NDC 68071-4784-1 BOTTLES OF 100

How Supplied

100 mg Capsules (White/White colored, size 3 hard gelatin capsules with 103 printed on body of capsules containing white to off white granular powder) NDC 68071-4784-1 BOTTLES OF 100

Medication Information

How Supplied

100 mg Capsules (White/White colored, size 3 hard gelatin capsules with 103 printed on body of capsules containing white to off white granular powder)

NDC 68071-4784-1 BOTTLES OF 100

Description

100 mg Capsules (White/White colored, size 3 hard gelatin capsules with 103 printed on body of capsules containing white to off white granular powder) NDC 68071-4784-1 BOTTLES OF 100

Section 42231-1

Section 51945-4

Structured Label Content

Section 42231-1 (42231-1)

Section 51945-4 (51945-4)

How Supplied (HOW SUPPLIED)

100 mg Capsules (White/White colored, size 3 hard gelatin capsules with 103 printed on body of capsules containing white to off white granular powder)

NDC 68071-4784-1 BOTTLES OF 100

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GABAPENTIN", "unii": "6CW7F3G59X", "classCode": "ACTIB", "strengthNumerator": "300", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"HOW SUPPLIED": "100 mg Capsules (White/White colored, size 3 hard gelatin capsules with 103 printed on body of capsules containing white to off white granular powder) NDC 68071-4784-1 BOTTLES OF 100"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:41:31.306983 · Updated: 2026-03-14T22:06:01.579611