This site is intended for healthcare professionals
FDA Hero  Banner - Multi-coloured pills and tablets
FDA Drug information

GABAPENTIN

Read time: 1 mins
Marketing start date: 02 May 2024

Summary of product characteristics


Effective Time

20190808

Version

1

Spl Product Data Elements

GABAPENTIN GABAPENTIN STARCH, CORN TALC TITANIUM DIOXIDE SHELLAC LACTOSE MONOHYDRATE ANHYDROUS LACTOSE FERRIC OXIDE YELLOW PROPYLENE GLYCOL GELATIN GABAPENTIN GABAPENTIN 104

Application Number

ANDA090007

Brand Name

GABAPENTIN

Generic Name

GABAPENTIN

Product Ndc

61919-640

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

640-72

How Supplied

300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.