OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Neurontin

gabapentin · Tablet, Film Coated

Prescription NDA TE AB1 RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Neurontin
Generic name
gabapentin
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Viatris Specialty LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Gabapentin 600 mg/1 310430 View
Gabapentin 800 mg/1 310430 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Central Nervous System Disorganized Electrical Activity [PE] PE All 114 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020882
Application type
NDA · New Drug Application
Approval date
October 9, 1998
Sponsor
VIATRIS
Products on application
2
Submissions recorded
27
Products approved under application 020882.
Product Trade name Form Strength Ingredient Status TE Flags
020882-001 NEURONTIN TABLET GABAPENTIN Prescription AB1 RLD
020882-002 NEURONTIN TABLET GABAPENTIN Prescription AB1 RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB1
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020882.
Type No. Action Status Date Review
Supplement 60 Labeling Approved April 25, 2025 Standard
Supplement 57 Labeling Approved July 12, 2024 Standard
Supplement 50 Labeling Approved December 16, 2020 Standard
Supplement 49 Labeling Approved April 2, 2020 901 Required
Supplement 47 Labeling Approved October 18, 2017 Standard
Supplement 45 Labeling Approved March 24, 2017 Standard
Supplement 43 Labeling Approved September 14, 2015 Standard
Supplement 44 Labeling Approved April 21, 2015 Standard
Supplement 41 Labeling Approved August 18, 2014 Standard
Supplement 40 Labeling Approved May 1, 2013 Standard
Supplement 39 Labeling Approved May 1, 2013 Standard
Supplement 38 Labeling Approved May 1, 2013 Standard
Supplement 35 Labeling Approved August 10, 2011 Unknown
Supplement 22 Labeling Approved March 1, 2011 Standard
Supplement 30 Labeling Approved October 11, 2010 Standard
Supplement 28 Labeling Approved April 23, 2009 901 Required
Supplement 21 Labeling Approved May 3, 2006 Standard
Supplement 15 Labeling Approved February 18, 2005 Standard
Supplement 17 Manufacturing (CMC) Approved April 30, 2004 Standard
Supplement 12 Manufacturing (CMC) Approved December 19, 2002 Standard
Supplement 10 Manufacturing (CMC) Approved October 24, 2002 Standard
Supplement 9 Efficacy Approved August 15, 2002 Standard
Supplement 8 Labeling Approved January 30, 2002 Standard
Supplement 7 Manufacturing (CMC) Approved January 18, 2002 Standard
Supplement 2 Efficacy Approved October 12, 2000 Standard
Supplement 5 Manufacturing (CMC) Approved September 19, 2000 Standard
Original application 1 Type 3 - New Dosage Form Approved October 9, 1998 Standard

Review documents

  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · April 29, 2025
  • 0 · Supplement · April 29, 2025
  • 0 · Supplement · July 18, 2024
  • 0 · Supplement · July 15, 2024
  • 0 · Supplement · December 21, 2020
  • 0 · Supplement · December 21, 2020
  • 0 · Supplement · October 26, 2020
  • 0 · Supplement · April 10, 2020
  • 0 · Supplement · April 3, 2020
  • 0 · Supplement · October 19, 2017
  • 0 · Supplement · March 29, 2017
  • 0 · Supplement · March 27, 2017
  • 0 · Supplement · September 23, 2015
  • 0 · Supplement · September 17, 2015
  • 0 · Supplement · April 27, 2015
  • 0 · Supplement · April 22, 2015
  • 0 · Supplement · August 20, 2014
  • 0 · Supplement · August 20, 2014
  • 0 · Supplement · May 9, 2013
  • 0 · Supplement · May 9, 2013
  • 0 · Supplement · May 9, 2013
  • 0 · Supplement · May 7, 2013
  • 0 · Supplement · May 7, 2013
  • 0 · Supplement · May 7, 2013
  • 0 · Supplement · August 12, 2011
  • 0 · Supplement · August 11, 2011
  • 0 · Supplement · March 7, 2011
  • 0 · Supplement · March 4, 2011
  • 0 · Supplement · October 13, 2010

Adverse event reports

Source: openFDA FAERS
365,168
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: GABAPENTIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
58151-284-01 58151-284 Viatris Specialty LLC 100 TABLET, FILM COATED in 1 BOTTLE (58151-284-01) October 1, 2025
58151-285-01 58151-285 Viatris Specialty LLC 100 TABLET, FILM COATED in 1 BOTTLE (58151-285-01) September 19, 2025
58151-284 58151-284 Viatris Specialty LLC — October 1, 2025
58151-285 58151-285 Viatris Specialty LLC — September 19, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.