FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-2356
11-digit product format
705182356
Labeler code
70518
Product ID
70518-2356_4ddcd63f-caf8-5ed6-e063-6394a90a9e54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200651
Marketing category
ANDA
Marketing start
2019-10-09
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
70518-2356-0Gabapentin30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-2356-1Gabapentin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-2356-2Gabapentin120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12013
70518-2356-3Gabapentin180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2356-1EA - Each70518-2356d4172074-e690-44f3-ac2d-defca7e20c5312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2356GABAPENTIN TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250312_5a78ab50-993d-4857-be10-be665e02b353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN5a78ab50-993d-4857-be10-be665e02b35313
310433gabapentin 600 MG Oral TabletSCD5a78ab50-993d-4857-be10-be665e02b35313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2356-07051823560030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2356-0) 2019-10-090000-00-00NoNoCurrent
70518-2356-17051823560190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-1) 2019-10-210000-00-00NoNoCurrent
70518-2356-270518235602120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-2) 2020-05-130000-00-00NoNoCurrent
70518-2356-370518235603180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-3) 2020-05-210000-00-00NoNoCurrent