FDA.reportPublic FDA data

Gabapentin

Product NDC
16714-332
11-digit product format
167140332
Labeler code
16714
Product ID
16714-332_e1bc9060-641c-4196-acfd-676a3d263fed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

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
16714-332-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED10018
16714-332-02Gabapentin500 in 1 BOTTLETABLET, FILM COATED50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-332-01EA - Each16714-33290bf6ddb-abb3-4036-910a-0d5a839a215412012-07-24
16714-332-02EA - Each16714-3328f11c302-898d-43c5-816b-328eabe4a42712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-332GABAPENTIN TABLET, FILM COATED [NORTHSTAR RX LLC]17Current NDC, Legacy NDC, 2 package rows20241018_9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a18
310434gabapentin 800 MG Oral TabletPSN9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a18
310433gabapentin 600 MG Oral TabletSCD9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a18
310434gabapentin 800 MG Oral TabletSCD9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a18
310434gabapentin 800 MG Oral TabletPSNafa28969-91c8-83fd-e053-2a95a90a656b6
310434gabapentin 800 MG Oral TabletSCDafa28969-91c8-83fd-e053-2a95a90a656b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-332-0116714033201100 TABLET, FILM COATED in 1 BOTTLE (16714-332-01) 2011-10-060000-00-00NoNoCurrent
16714-332-0216714033202500 TABLET, FILM COATED in 1 BOTTLE (16714-332-02) 2011-10-060000-00-00NoNoCurrent