GABAPENTIN

Product NDC
61919-350
11-digit product format
619190350
Labeler code
61919
Product ID
61919-350_ea4e5538-f213-70bc-e053-2995a90a735a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077662
Marketing category
ANDA
Marketing start
2019-08-08
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
No
Listing certified through
2023-12-31
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
61919-350-902024-01-30C16284748780-11030e365-6c83-111a-e063-dadaa90a10e2GABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-350-90GABAPENTIN90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-350-30EA - Each61919-35000f78836-5b67-4554-b98f-9b3ffa9dffc312019-09-05
61919-350-60EA - Each61919-350bd33e084-37b8-4696-bb1c-b6508d4812a312019-09-05
61919-350-72EA - Each61919-350dab0c5de-313d-4540-a8cc-d359a25eb43712021-02-05
61919-350-90EA - Each61919-35027dfe1af-cdee-48a1-8a51-8de7050855c512016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-350GABAPENTIN 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
61919-350-306191903503030 TABLET in 1 BOTTLE (61919-350-30) 30 tablet2019-08-080000-00-00NoNoCurrent
61919-350-606191903506060 TABLET in 1 BOTTLE (61919-350-60) 60 tablet2019-08-080000-00-00NoNoCurrent
61919-350-7261919035072120 TABLET in 1 BOTTLE (61919-350-72) 120 tablet2019-08-080000-00-00NoNoCurrent
61919-350-906191903509090 TABLET in 1 BOTTLE (61919-350-90) 90 tablet2016-03-160000-00-00NoNoCurrent