Gabapentin

Product NDC
42254-112
11-digit product format
422540112
Labeler code
42254
Product ID
42254-112_3345e995-7c5a-4e1c-949a-396ca7332023
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-112-302019-09-24C16284748780-19350213a-3dbb-c013-e053-90daa90a1393Gabapentin Capsules
42254-112-602019-09-24C16284748780-19350213a-3dbb-c013-e053-90daa90a1393Gabapentin Capsules
42254-112-902019-09-24C16284748780-19350213a-3dbb-c013-e053-90daa90a1393Gabapentin Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-112-30Gabapentin30 in 1 BOTTLECAPSULE303
42254-112-60Gabapentin60 in 1 BOTTLECAPSULE603
42254-112-90Gabapentin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-112-30EA - Each42254-112d7f8ccc2-7ee9-424f-9f18-e7260ec98f7f12013-02-13
42254-112-60EA - Each42254-112d1db16d1-fff7-4741-9f83-29c92c54c9be12012-07-24
42254-112-90EA - Each42254-11224dde7b3-3ab5-4be9-9736-f1fad2284b8512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-112GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]3Legacy NDC, 3 package rows20121208_591e0212-71ac-4f7a-b30a-8f4b745b263b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN591e0212-71ac-4f7a-b30a-8f4b745b263b3
310432gabapentin 400 MG Oral CapsulePSN591e0212-71ac-4f7a-b30a-8f4b745b263b3
310430gabapentin 100 MG Oral CapsuleSCD591e0212-71ac-4f7a-b30a-8f4b745b263b3
310432gabapentin 400 MG Oral CapsuleSCD591e0212-71ac-4f7a-b30a-8f4b745b263b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-112-304225401123030 in 1 BOTTLEHistorical
42254-112-604225401126060 in 1 BOTTLEHistorical
42254-112-904225401129090 in 1 BOTTLEHistorical