FDA.reportPublic FDA data

Gabapentin

Product NDC
43063-611
11-digit product format
430630611
Labeler code
43063
Product ID
43063-611_509f536a-edf8-4baf-e063-6394a90a738d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078926
Marketing category
ANDA
Marketing start
2012-10-16
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

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
43063-611-60Gabapentin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
43063-611-90Gabapentin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-611-60EA - Each43063-61191bd9678-3508-40be-ae11-a5ba6762936812025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-611GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20250130_d22ed424-f365-44ca-8ef9-a08255a90ae8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNd22ed424-f365-44ca-8ef9-a08255a90ae821
310434gabapentin 800 MG Oral TabletSCDd22ed424-f365-44ca-8ef9-a08255a90ae821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-611-604306306116060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-611-60) 2025-01-29NoNoHistorical
43063-611-904306306119090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-611-90) 2015-05-040000-00-00NoNoCurrent