GABAPENTIN

Product NDC
61919-417
11-digit product format
619190417
Labeler code
61919
Product ID
61919-417_8643994f-4e6e-4572-e053-2991aa0a5b78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090705
Marketing category
ANDA
Marketing start
2017-12-05
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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
61919-417-602024-01-30C16284748780-11030e365-6c83-111a-e063-dadaa90a10e2GABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-417-60GABAPENTIN60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-417-60EA - Each61919-4171cb7af49-e244-4cb4-aa81-47dc360da32412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-417GABAPENTIN TABLET GABAPENTIN CAPSULE [DIRECT RX]3Legacy NDC, 1 package rows20190412_2e319a08-901d-40a9-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN2e319a08-901d-40a9-e054-00144ff88e883
310431gabapentin 300 MG Oral CapsulePSN2e319a08-901d-40a9-e054-00144ff88e883
310434gabapentin 800 MG Oral TabletPSN2e319a08-901d-40a9-e054-00144ff88e883
310430gabapentin 100 MG Oral CapsuleSCD2e319a08-901d-40a9-e054-00144ff88e883
310431gabapentin 300 MG Oral CapsuleSCD2e319a08-901d-40a9-e054-00144ff88e883
310434gabapentin 800 MG Oral TabletSCD2e319a08-901d-40a9-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-417-606191904176060 CAPSULE in 1 BOTTLE (61919-417-60) 60 capsule2019-04-090000-00-00NoNoCurrent