FDA.reportPublic FDA data

Gabapentin

Product NDC
16714-663
11-digit product format
167140663
Labeler code
16714
Product ID
16714-663_2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
16714-663-01Gabapentin100 in 1 BOTTLECAPSULE10019
16714-663-02Gabapentin500 in 1 BOTTLECAPSULE50019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-663GABAPENTIN CAPSULE [NORTHSTAR RX LLC]18Current NDC, Legacy NDC, 2 package rows20241115_f7c1fd34-d615-43a2-8989-898fe11f90df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNf7c1fd34-d615-43a2-8989-898fe11f90df19
310431gabapentin 300 MG Oral CapsulePSNf7c1fd34-d615-43a2-8989-898fe11f90df19
310432gabapentin 400 MG Oral CapsulePSNf7c1fd34-d615-43a2-8989-898fe11f90df19
310430gabapentin 100 MG Oral CapsuleSCDf7c1fd34-d615-43a2-8989-898fe11f90df19
310431gabapentin 300 MG Oral CapsuleSCDf7c1fd34-d615-43a2-8989-898fe11f90df19
310432gabapentin 400 MG Oral CapsuleSCDf7c1fd34-d615-43a2-8989-898fe11f90df19
310430gabapentin 100 MG Oral CapsulePSNd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310432gabapentin 400 MG Oral CapsulePSNd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310430gabapentin 100 MG Oral CapsuleSCDd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310432gabapentin 400 MG Oral CapsuleSCDd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310432gabapentin 400 MG Oral CapsulePSNb33c18ea-554d-3cfb-e053-2a95a90a2dd16
310432gabapentin 400 MG Oral CapsuleSCDb33c18ea-554d-3cfb-e053-2a95a90a2dd16
310432gabapentin 400 MG Oral CapsulePSN1e28ad3d-2d34-a5d0-e063-6294a90adb9e1
310432gabapentin 400 MG Oral CapsuleSCD1e28ad3d-2d34-a5d0-e063-6294a90adb9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-663-0116714066301100 CAPSULE in 1 BOTTLE (16714-663-01) 100 capsule2008-01-310000-00-00NoNoCurrent
16714-663-0216714066302500 CAPSULE in 1 BOTTLE (16714-663-02) 500 capsule2008-01-310000-00-00NoNoCurrent