GABAPENTIN

Product NDC
61919-563
11-digit product format
619190563
Labeler code
61919
Product ID
61919-563_4193f1e3-7042-5187-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202764
Marketing category
ANDA
Marketing start
2016-08-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-563-30GABAPENTIN30 in 1 BOTTLETABLET304
61919-563-60GABAPENTIN60 in 1 BOTTLETABLET604
61919-563-72GABAPENTIN120 in 1 BOTTLETABLET1204
61919-563-90GABAPENTIN90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-563-30EA - Each61919-563e6449427-8c68-4ed2-bff6-acd124f6945912016-10-06
61919-563-60EA - Each61919-5639958b903-b2bf-47ed-80a2-2e2bbcedc16c12016-10-06
61919-563-72EA - Each61919-563fd6df843-01ad-4924-b829-1389a2017b9312016-10-06
61919-563-90EA - Each61919-563119f9602-9da1-4ceb-92ca-e90271af71f012016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-563GABAPENTIN TABLET [DIRECT RX]4Legacy NDC, 4 package rows20161118_3b4fc24e-bf30-7203-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN3b4fc24e-bf30-7203-e054-00144ff8d46c4
310433gabapentin 600 MG Oral TabletSCD3b4fc24e-bf30-7203-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-563-306191905633030 in 1 BOTTLEHistorical
61919-563-606191905636060 in 1 BOTTLEHistorical
61919-563-7261919056372120 in 1 BOTTLEHistorical
61919-563-906191905639090 in 1 BOTTLEHistorical