FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-1469
11-digit product format
705181469
Labeler code
70518
Product ID
70518-1469_490ec676-81a2-6ba1-e063-6394a90a5039
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090858
Marketing category
ANDA
Marketing start
2018-10-05
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310432

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
70518-1469-0Gabapentin30 in 1 BLISTER PACKCAPSULE3019
70518-1469-1Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9019
70518-1469-2Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE18019
70518-1469-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3019
70518-1469-4Gabapentin100 in 1 BOXCAPSULE10019
70518-1469-5Gabapentin1 in 1 POUCHCAPSULE119
70518-1469-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE6019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1469GABAPENTIN CAPSULE [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 7 package rows20250223_78445dbf-c7cd-419f-a7be-72821e496628.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN78445dbf-c7cd-419f-a7be-72821e49662819
310432gabapentin 400 MG Oral CapsuleSCD78445dbf-c7cd-419f-a7be-72821e49662819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1469-07051814690030 CAPSULE in 1 BLISTER PACK (70518-1469-0) 30 capsule2018-10-050000-00-00NoNoCurrent
70518-1469-17051814690190 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-1) 90 capsule2019-07-090000-00-00NoNoCurrent
70518-1469-270518146902180 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-2) 180 capsule2019-07-090000-00-00NoNoCurrent
70518-1469-37051814690330 in 1 BOTTLE, PLASTICHistorical
70518-1469-470518146904100 POUCH in 1 BOX (70518-1469-4) / 1 CAPSULE in 1 POUCH (70518-1469-5) 100 pouch2018-10-05NoNoHistorical
70518-1469-5705181469051 in 1 POUCHHistorical
70518-1469-67051814690660 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-6) 60 capsule2023-09-12NoNoHistorical