Gabapentin

Product NDC
10544-185
11-digit product format
105440185
Labeler code
10544
Product ID
10544-185_1ec1a2d2-81a8-4b6d-ab02-62881d82facf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078787
Marketing category
ANDA
Marketing start
2010-10-08
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
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
10544-185-302019-10-29C16284748780-1960f7f55-d16c-8e05-e053-dbdaa90a074aGabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-185-30Gabapentin30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-185GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20101013_7e351770-8975-4417-a599-feaa3cba7514.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN7e351770-8975-4417-a599-feaa3cba75141
310430gabapentin 100 MG Oral CapsuleSCD7e351770-8975-4417-a599-feaa3cba75141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-185-301054401853030 in 1 BOTTLEHistorical