FDA.reportPublic FDA data

Gabapentin

Product NDC
52125-816
11-digit product format
521250816
Labeler code
52125
Product ID
52125-816_36fca15b-d0df-4213-a2be-811d74714d49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202764
Marketing category
ANDA
Marketing start
2014-01-30
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52125-816-022019-11-27C16284748780-19855e2a2-476a-60a7-e053-dbdaa90a05bdGabapentin Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52125-816-02Gabapentin30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [REMEDYREPACK INC. ]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [REMEDYREPACK INC. ]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET [REMEDYREPACK INC. ]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET [REMEDYREPACK INC. ]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [REMEDYREPACK INC. ]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [REMEDYREPACK INC. ]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET [REMEDYREPACK INC. ]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [REMEDYREPACK INC. ]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [REMEDYREPACK INC. ]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [REMEDYREPACK INC. ]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [REMEDYREPACK INC. ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52125-816GABAPENTIN TABLET [REMEDYREPACK INC. ]1Legacy NDC, 1 package rows20140131_3769f1e4-a5ff-43b8-9128-124bc35346d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN3769f1e4-a5ff-43b8-9128-124bc35346d01
310433gabapentin 600 MG Oral TabletSCD3769f1e4-a5ff-43b8-9128-124bc35346d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52125-816-025212508160230 in 1 BLISTER PACKHistorical