FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-2842
11-digit product format
705182842
Labeler code
70518
Product ID
70518-2842_4ab769da-4554-e9a5-e063-6294a90a767d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206402
Marketing category
ANDA
Marketing start
2020-08-20
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2842-0Gabapentin28 in 1 BLISTER PACKTABLET2811
70518-2842-1Gabapentin100 in 1 BOXTABLET10011
70518-2842-2Gabapentin1 in 1 POUCHTABLET111
70518-2842-3Gabapentin90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2842GABAPENTIN TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250406_81243958-cc5a-4ec0-a64d-71682f949d5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN81243958-cc5a-4ec0-a64d-71682f949d5f11
310433gabapentin 600 MG Oral TabletSCD81243958-cc5a-4ec0-a64d-71682f949d5f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2842-07051828420028 TABLET in 1 BLISTER PACK (70518-2842-0) 28 tablet2020-08-200000-00-00NoNoCurrent
70518-2842-170518284201100 POUCH in 1 BOX (70518-2842-1) / 1 TABLET in 1 POUCH (70518-2842-2) 100 pouch2021-08-050000-00-00NoNoCurrent
70518-2842-2705182842021 in 1 POUCHHistorical
70518-2842-37051828420390 TABLET in 1 BOTTLE, PLASTIC (70518-2842-3) 90 tablet2025-11-03NoNoHistorical