FDA.reportPublic FDA data

Gabapentin

Product NDC
10544-439
11-digit product format
105440439
Labeler code
10544
Product ID
10544-439_2adeb324-8a46-15aa-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077662
Marketing category
ANDA
Marketing start
2014-02-07
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-439-022020-01-31C16284748780-19d75b9cf-fc38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
10544-439-302020-01-31C16284748780-19d75b9cf-fc38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
10544-439-602020-01-31C16284748780-19d75b9cf-fc38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
10544-439-902020-01-31C16284748780-19d75b9cf-fc38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-439-02Gabapentin120 in 1 BOTTLETABLET1207
10544-439-30Gabapentin30 in 1 BOTTLETABLET307
10544-439-60Gabapentin60 in 1 BOTTLETABLET607
10544-439-90Gabapentin90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-439-02EA - Each10544-43902eda4e5-9782-4332-a9e1-e3041fa3f90c12015-04-03
10544-439-30EA - Each10544-43919c0ce51-c7f5-4b48-b55f-274ba9d4186e12015-04-03
10544-439-60EA - Each10544-4393340d439-e42d-4e37-92cc-a6af2a1eda4812015-04-03
10544-439-90EA - Each10544-439123ad48f-8b48-4468-be05-b5889d8b31e912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-439GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.]7Legacy NDC, 4 package rows20160203_383fd4de-4d2a-42dc-9a15-48bee7efb0ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN383fd4de-4d2a-42dc-9a15-48bee7efb0ba7
310434gabapentin 800 MG Oral TabletPSN383fd4de-4d2a-42dc-9a15-48bee7efb0ba7
310433gabapentin 600 MG Oral TabletSCD383fd4de-4d2a-42dc-9a15-48bee7efb0ba7
310434gabapentin 800 MG Oral TabletSCD383fd4de-4d2a-42dc-9a15-48bee7efb0ba7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-439-0210544043902120 in 1 BOTTLEHistorical
10544-439-301054404393030 in 1 BOTTLEHistorical
10544-439-601054404396060 in 1 BOTTLEHistorical
10544-439-901054404399090 in 1 BOTTLEHistorical