FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-2616
11-digit product format
705182616
Labeler code
70518
Product ID
70518-2616_4a7a5fa7-ae72-42cf-e063-6394a90a90ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200651
Marketing category
ANDA
Marketing start
2020-03-09
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
70518-2616-0Gabapentin30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-2616-1Gabapentin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9017
70518-2616-2Gabapentin28 in 1 BLISTER PACKTABLET, FILM COATED2817
70518-2616-3Gabapentin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
70518-2616-4Gabapentin100 in 1 BOXTABLET, FILM COATED10017
70518-2616-5Gabapentin1 in 1 POUCHTABLET, FILM COATED117
70518-2616-6Gabapentin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN7ddc7d92-9076-41cf-97ed-d9f9edc8029817
310433gabapentin 600 MG Oral TabletSCD7ddc7d92-9076-41cf-97ed-d9f9edc8029817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2616-07051826160030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2616-0) 2020-03-090000-00-00NoNoCurrent
70518-2616-17051826160190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2616-1) 2021-01-040000-00-00NoNoCurrent
70518-2616-27051826160228 TABLET, FILM COATED in 1 BLISTER PACK (70518-2616-2) 2021-02-250000-00-00NoNoCurrent
70518-2616-37051826160330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2616-3) 2022-04-050000-00-00NoNoCurrent
70518-2616-470518261604100 in 1 BOXHistorical
70518-2616-5705182616051 in 1 POUCHHistorical
70518-2616-67051826160660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2616-6) 2025-06-18NoNoHistorical