GABAPENTIN

Product NDC
0440-5562
11-digit product format
004405562
Labeler code
0440
Product ID
0440-5562_29c0c23b-f87d-4a94-a411-4091f399ecd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA202764
Marketing category
ANDA
Marketing start
2012-11-02
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
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-5562-05GABAPENTIN500 in 1 BOTTLETABLET, FILM COATED5001
0440-5562-30GABAPENTIN30 in 1 BOTTLETABLET, FILM COATED301
0440-5562-60GABAPENTIN60 in 1 BOTTLETABLET, FILM COATED601
0440-5562-81GABAPENTIN300 in 1 BOTTLETABLET, FILM COATED3001
0440-5562-90GABAPENTIN90 in 1 BOTTLETABLET, FILM COATED901
0440-5562-91GABAPENTIN120 in 1 BOTTLETABLET, FILM COATED1201
0440-5562-92GABAPENTIN180 in 1 BOTTLETABLET, FILM COATED1801
0440-5562-94GABAPENTIN270 in 1 BOTTLETABLET, FILM COATED2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-5562-05EA - Each0440-5562d0f30bac-02d2-45bc-b249-ae927419cabf12018-04-19
0440-5562-30EA - Each0440-5562049fbd72-3e34-4aa2-bbd9-91719b52f5e912018-04-19
0440-5562-60EA - Each0440-5562f1dbf957-2922-4992-9c8b-57f54ee8408312018-04-19
0440-5562-81EA - Each0440-55628fbd99db-e40e-4852-9632-0c7f855a5dba12018-04-19
0440-5562-90EA - Each0440-55629cbdba36-2007-4fe5-9331-eddf2e9abefc12018-04-19
0440-5562-91EA - Each0440-55626ca3f478-306f-4d9f-ab00-9aa056f0568412018-04-19
0440-5562-92EA - Each0440-55621d5bfd59-aa9b-4d0d-9e2a-36eba0cc1b8d12018-04-19
0440-5562-94EA - Each0440-5562b2a328d9-635c-4b15-9610-4823c2fde4a912018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-5562GABAPENTIN TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 8 package rows20160810_0002eded-a283-4590-a78c-b6ff2027e684.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN0002eded-a283-4590-a78c-b6ff2027e6841
310434gabapentin 800 MG Oral TabletPSN0002eded-a283-4590-a78c-b6ff2027e6841
310433gabapentin 600 MG Oral TabletSCD0002eded-a283-4590-a78c-b6ff2027e6841
310434gabapentin 800 MG Oral TabletSCD0002eded-a283-4590-a78c-b6ff2027e6841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-5562-0500440556205500 in 1 BOTTLEHistorical
0440-5562-300044055623030 in 1 BOTTLEHistorical
0440-5562-600044055626060 in 1 BOTTLEHistorical
0440-5562-8100440556281300 in 1 BOTTLEHistorical
0440-5562-900044055629090 in 1 BOTTLEHistorical
0440-5562-9100440556291120 in 1 BOTTLEHistorical
0440-5562-9200440556292180 in 1 BOTTLEHistorical
0440-5562-9400440556294270 in 1 BOTTLEHistorical