Gabapentin

Product NDC
16714-330
11-digit product format
167140330
Labeler code
16714
Product ID
16714-330_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
600 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
GABAPENTIN600 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-330-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED10018
16714-330-02Gabapentin500 in 1 BOTTLETABLET, FILM COATED50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-330-01EA - Each16714-3307b58c66f-bc85-4b70-9dda-0bb3409e4a0312012-07-24
16714-330-02EA - Each16714-330550b3e57-7fd4-467b-be2b-fdd741523e2c12012-07-24

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
16714-330GABAPENTIN 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
310433gabapentin 600 MG Oral TabletPSN0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d3
310433gabapentin 600 MG Oral TabletPSN2343e3a1-82d0-4c70-a086-a01a0ce81ef33
310433gabapentin 600 MG Oral TabletSCD0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d3
310433gabapentin 600 MG Oral TabletSCD2343e3a1-82d0-4c70-a086-a01a0ce81ef33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-330-0116714033001100 TABLET, FILM COATED in 1 BOTTLE (16714-330-01) 2011-10-060000-00-00NoNoCurrent
16714-330-0216714033002500 TABLET, FILM COATED in 1 BOTTLE (16714-330-02) 2011-10-060000-00-00NoNoCurrent