GABAPENTIN

Product NDC
21695-059
11-digit product format
216950059
Labeler code
21695
Product ID
21695-059_95ceac2d-ce96-4d9d-9fe6-893940f1decb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA077525
Marketing category
ANDA
Marketing start
2006-08-24
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 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
21695-059-302019-09-24C16284748780-1934fe258-49a4-48b1-e053-8cdaa90a720aGabapentin Tablets, USP
21695-059-602019-09-24C16284748780-1934fe258-49a4-48b1-e053-8cdaa90a720aGabapentin Tablets, USP
21695-059-902019-09-24C16284748780-1934fe258-49a4-48b1-e053-8cdaa90a720aGabapentin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-059-30GABAPENTIN30 in 1 BOTTLETABLET, FILM COATED301
21695-059-60GABAPENTIN60 in 1 BOTTLETABLET, FILM COATED601
21695-059-90GABAPENTIN90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-059-30EA - Each21695-0591d439586-a882-4bbb-ac20-cd0c896a114812012-07-24
21695-059-60EA - Each21695-0594f1fe2a7-6aae-4453-9d6f-f4feb7a6bc7712012-07-24
21695-059-90EA - Each21695-0590f2dbd06-3448-4322-9184-5168a6cb9f1412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-059GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 3 package rows20091208_2fe659eb-a8b4-491b-9195-fe979d7f0373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN2fe659eb-a8b4-491b-9195-fe979d7f03731
310434gabapentin 800 MG Oral TabletPSN2fe659eb-a8b4-491b-9195-fe979d7f03731
310433gabapentin 600 MG Oral TabletSCD2fe659eb-a8b4-491b-9195-fe979d7f03731
310434gabapentin 800 MG Oral TabletSCD2fe659eb-a8b4-491b-9195-fe979d7f03731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-059-302169500593030 in 1 BOTTLEHistorical
21695-059-602169500596060 in 1 BOTTLEHistorical
21695-059-902169500599090 in 1 BOTTLEHistorical