Gabapentin

Product NDC
65862-523
11-digit product format
658620523
Labeler code
65862
Product ID
65862-523_700d09f5-99cc-492d-ab49-442f674d9c5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-523-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED10020
65862-523-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED50020
65862-523-26Gabapentin2500 in 1 BOTTLETABLET, FILM COATED250020
65862-523-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-523GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 4 package rows20250524_25cf6c40-a239-4dd0-9cad-28da84d285db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN25cf6c40-a239-4dd0-9cad-28da84d285db20
310434gabapentin 800 MG Oral TabletPSN25cf6c40-a239-4dd0-9cad-28da84d285db20
310433gabapentin 600 MG Oral TabletSCD25cf6c40-a239-4dd0-9cad-28da84d285db20
310434gabapentin 800 MG Oral TabletSCD25cf6c40-a239-4dd0-9cad-28da84d285db20
310433gabapentin 600 MG Oral TabletPSN7ddc7d92-9076-41cf-97ed-d9f9edc8029817
310433gabapentin 600 MG Oral TabletSCD7ddc7d92-9076-41cf-97ed-d9f9edc8029817
310433gabapentin 600 MG Oral TabletPSN5a78ab50-993d-4857-be10-be665e02b35313
310433gabapentin 600 MG Oral TabletSCD5a78ab50-993d-4857-be10-be665e02b35313
310433gabapentin 600 MG Oral TabletPSNb37b1dcc-c7e9-8845-e053-2995a90a089e9
310433gabapentin 600 MG Oral TabletSCDb37b1dcc-c7e9-8845-e053-2995a90a089e9
310433gabapentin 600 MG Oral TabletPSN152adf1d-ec0c-4561-bf80-e4c7da1587238
310434gabapentin 800 MG Oral TabletPSN152adf1d-ec0c-4561-bf80-e4c7da1587238
310433gabapentin 600 MG Oral TabletSCD152adf1d-ec0c-4561-bf80-e4c7da1587238
310434gabapentin 800 MG Oral TabletSCD152adf1d-ec0c-4561-bf80-e4c7da1587238
310433gabapentin 600 MG Oral TabletPSN41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletPSN41f1e929-7c1f-4b3e-b142-4b7533300ee23
310433gabapentin 600 MG Oral TabletSCD41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletSCD41f1e929-7c1f-4b3e-b142-4b7533300ee23
310433gabapentin 600 MG Oral TabletPSN8f982b95-4e84-4e0c-a543-747bc3dd75311
310433gabapentin 600 MG Oral TabletPSNd0510d04-460c-47d1-be72-0ee32c4ac6401
310433gabapentin 600 MG Oral TabletSCD8f982b95-4e84-4e0c-a543-747bc3dd75311
310433gabapentin 600 MG Oral TabletSCDd0510d04-460c-47d1-be72-0ee32c4ac6401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-523-0165862052301100 TABLET, FILM COATED in 1 BOTTLE (65862-523-01) 2011-10-060000-00-00NoNoCurrent
65862-523-0565862052305500 TABLET, FILM COATED in 1 BOTTLE (65862-523-05) 2011-10-060000-00-00NoNoCurrent
65862-523-15658620523151500 TABLET, FILM COATED in 1 BAG (65862-523-15)06-OCT-11Current
65862-523-26658620523262500 TABLET, FILM COATED in 1 BOTTLE (65862-523-26) 2011-10-060000-00-00NoNoCurrent
65862-523-296586205232920000 TABLET, FILM COATED in 1 BAG (65862-523-29)07-MAY-20Current
65862-523-906586205239090 TABLET, FILM COATED in 1 BOTTLE (65862-523-90) 2011-10-060000-00-00NoNoCurrent