Gabapentin

Product NDC
65862-524
11-digit product format
658620524
Labeler code
65862
Product ID
65862-524_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
800 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
GABAPENTIN800 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
65862-524-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED10020
65862-524-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED50020
65862-524-31Gabapentin1700 in 1 BOTTLETABLET, FILM COATED170020
65862-524-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-524GABAPENTIN 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
310434gabapentin 800 MG Oral TabletPSN429a1bb5-babf-4f36-8264-46d71164f1c014
310434gabapentin 800 MG Oral TabletSCD429a1bb5-babf-4f36-8264-46d71164f1c014
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
310434gabapentin 800 MG Oral TabletPSNc898711b-9a65-1816-e053-2995a90a855e6
310434gabapentin 800 MG Oral TabletSCDc898711b-9a65-1816-e053-2995a90a855e6
310433gabapentin 600 MG Oral TabletPSN41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletPSN41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletPSNc79d94ec-117d-4fb6-845d-1954e3472bb03
310433gabapentin 600 MG Oral TabletSCD41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletSCD41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletSCDc79d94ec-117d-4fb6-845d-1954e3472bb03
310434gabapentin 800 MG Oral TabletPSNa5b47f89-ed35-31de-e053-2a95a90a55542
310434gabapentin 800 MG Oral TabletSCDa5b47f89-ed35-31de-e053-2a95a90a55542
310434gabapentin 800 MG Oral TabletPSNbe9a572d-e98a-41c1-83c5-859d9176dd1c1
310434gabapentin 800 MG Oral TabletPSNd9d78138-e1e9-4107-9099-4910cb1422d81
310434gabapentin 800 MG Oral TabletSCDbe9a572d-e98a-41c1-83c5-859d9176dd1c1
310434gabapentin 800 MG Oral TabletSCDd9d78138-e1e9-4107-9099-4910cb1422d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-524-0165862052401100 TABLET, FILM COATED in 1 BOTTLE (65862-524-01) 2011-10-060000-00-00NoNoCurrent
65862-524-0565862052405500 TABLET, FILM COATED in 1 BOTTLE (65862-524-05) 2011-10-060000-00-00NoNoCurrent
65862-524-31658620524311700 TABLET, FILM COATED in 1 BOTTLE (65862-524-31) 2011-10-060000-00-00NoNoCurrent
65862-524-556586205245515000 TABLET, FILM COATED in 1 BAG (65862-524-55)07-MAY-20Current
65862-524-906586205249090 TABLET, FILM COATED in 1 BOTTLE (65862-524-90) 2011-10-060000-00-00NoNoCurrent
65862-524-99658620524991000 TABLET, FILM COATED in 1 BAG (65862-524-99)06-OCT-11Current