FDA.reportPublic FDA data

GABAPENTIN

Product NDC
61919-252
11-digit product format
619190252
Labeler code
61919
Product ID
61919-252_9c9437d9-bfa5-2a03-e053-2a95a90aeded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075350
Marketing category
ANDA
Marketing start
2019-08-08
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
61919-252-722022-01-28C16284748780-1d6a99b39-a04d-a426-e053-dadaa90af4c2GABAPENTIN
61919-252-302020-01-31C16284748780-19d75b9d0-28ba-f424-e053-dadaa90a57ceGABAPENTIN
61919-252-602020-01-31C16284748780-19d75b9d0-28ba-f424-e053-dadaa90a57ceGABAPENTIN
61919-252-902020-01-31C16284748780-19d75b9d0-28ba-f424-e053-dadaa90a57ceGABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-252-30GABAPENTIN30 in 1 BOTTLECAPSULE302
61919-252-60GABAPENTIN60 in 1 BOTTLECAPSULE602
61919-252-72GABAPENTIN120 in 1 BOTTLECAPSULE1202
61919-252-90GABAPENTIN90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-252GABAPENTIN CAPSULE [DIRECT_RX]2Legacy NDC, 1 package rows20200121_8f9fd7ca-a7c3-12f3-e053-2995a90aee44.zip
61919-252GABAPENTIN CAPSULE [DIRECTRX]2Legacy NDC, 3 package rows20170225_0cea4ac6-8aeb-4a84-91ee-e170e7dd89af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN0cea4ac6-8aeb-4a84-91ee-e170e7dd89af2
310430gabapentin 100 MG Oral CapsulePSN8f9fd7ca-a7c3-12f3-e053-2995a90aee442
310430gabapentin 100 MG Oral CapsuleSCD0cea4ac6-8aeb-4a84-91ee-e170e7dd89af2
310430gabapentin 100 MG Oral CapsuleSCD8f9fd7ca-a7c3-12f3-e053-2995a90aee442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-252-306191902523030 in 1 BOTTLEHistorical
61919-252-606191902526060 in 1 BOTTLEHistorical
61919-252-7261919025272120 CAPSULE in 1 BOTTLE (61919-252-72) 120 capsule2019-08-080000-00-00NoNoCurrent
61919-252-906191902529090 in 1 BOTTLEHistorical