FDA.reportPublic FDA data

GABAPENTIN

Product NDC
61919-387
11-digit product format
619190387
Labeler code
61919
Product ID
61919-387_a23fa840-b83d-d01f-e053-2995a90a4ead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA203244
Marketing category
ANDA
Marketing start
2018-02-01
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
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
61919-387-302025-01-30C16284748780-12cef2736-9f06-d83d-e063-dadaa90ab31fGABAPENTIN
61919-387-602025-01-30C16284748780-12cef2736-9f06-d83d-e063-dadaa90ab31fGABAPENTIN
61919-387-722025-01-30C16284748780-12cef2736-9f06-d83d-e063-dadaa90ab31fGABAPENTIN
61919-387-862025-01-30C16284748780-12cef2736-9f06-d83d-e063-dadaa90ab31fGABAPENTIN
61919-387-902025-01-30C16284748780-12cef2736-9f06-d83d-e063-dadaa90ab31fGABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-387-30GABAPENTIN30 in 1 BOTTLETABLET, FILM COATED307
61919-387-60GABAPENTIN60 in 1 BOTTLETABLET, FILM COATED607
61919-387-72GABAPENTIN120 in 1 BOTTLETABLET, FILM COATED1207
61919-387-86GABAPENTIN270 in 1 BOTTLETABLET, FILM COATED2707
61919-387-90GABAPENTIN90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-387-30EA - Each61919-387be6fdcee-d13b-4389-854b-cf821017b2f312018-04-19
61919-387-60EA - Each61919-387203db489-fa9d-4332-86b9-42ac0564c2da12018-04-19
61919-387-72EA - Each61919-387d2df637a-c099-4097-81ef-75c27e9b183212018-04-19
61919-387-86EA - Each61919-387111ec2bf-178a-408b-935a-9be2540d497912018-04-19
61919-387-90EA - Each61919-387ca2bc4f5-5258-49cd-88bc-50370ee58bae12018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [DIRECT RX]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET [DIRECT RX]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [DIRECT RX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-387GABAPENTIN TABLET, FILM COATED [DIRECT RX]7Legacy NDC, 5 package rows20200402_01aafb0d-6cf4-406d-baad-560a6c91b33f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN01aafb0d-6cf4-406d-baad-560a6c91b33f7
310433gabapentin 600 MG Oral TabletSCD01aafb0d-6cf4-406d-baad-560a6c91b33f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-387-306191903873030 TABLET, FILM COATED in 1 BOTTLE (61919-387-30) 2018-02-010000-00-00NoNoCurrent
61919-387-606191903876060 TABLET, FILM COATED in 1 BOTTLE (61919-387-60) 2018-02-010000-00-00NoNoCurrent
61919-387-7261919038772120 TABLET, FILM COATED in 1 BOTTLE (61919-387-72) 2018-02-010000-00-00NoNoCurrent
61919-387-8661919038786270 TABLET, FILM COATED in 1 BOTTLE (61919-387-86) 2018-02-010000-00-00NoNoCurrent
61919-387-906191903879090 TABLET, FILM COATED in 1 BOTTLE (61919-387-90) 2018-02-010000-00-00NoNoCurrent