Gabapentin

Product NDC
31722-405
11-digit product format
317220405
Labeler code
31722
Product ID
31722-405_192c9a1b-374e-4ec3-a915-05495365d1d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202764
Marketing category
ANDA
Marketing start
2012-10-29
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-405-01EA - Each31722-405e374422a-329c-448e-a815-53cb932c037412013-02-13
31722-405-05EA - Each31722-40568f88d88-080f-4444-a4c0-f9dc007e859912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [REMEDYREPACK INC. ]1
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [RXCHANGE CO.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [RXCHANGE CO.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [REMEDYREPACK INC. ]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET [REMEDYREPACK INC. ]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN CAPSULE [RXCHANGE CO.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN CAPSULE [RXCHANGE CO.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET [REMEDYREPACK INC. ]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [REMEDYREPACK INC. ]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN CAPSULE [RXCHANGE CO.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE [RXCHANGE CO.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [REMEDYREPACK INC. ]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET [REMEDYREPACK INC. ]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [RXCHANGE CO.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN CAPSULE [RXCHANGE CO.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [REMEDYREPACK INC. ]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN CAPSULE [RXCHANGE CO.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [REMEDYREPACK INC. ]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [RXCHANGE CO.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [REMEDYREPACK INC. ]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [RXCHANGE CO.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [REMEDYREPACK INC. ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-405GABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]4Legacy NDC20151017_036c0c4f-edcc-4974-9ae1-5becb9654cab.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