Gabapentin

Product NDC
45865-347
11-digit product format
458650347
Labeler code
45865
Product ID
45865-347_62717c61-b047-49f2-ab29-a852dc5dead2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-347-30Gabapentin30 in 1 BOTTLECAPSULE301
45865-347-49Gabapentin100 in 1 BOTTLECAPSULE1001
45865-347-57Gabapentin180 in 1 BOTTLECAPSULE1801
45865-347-60Gabapentin60 in 1 BOTTLECAPSULE601
45865-347-90Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-347GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 5 package rows20120801_119ff7cc-5a38-490a-a982-7431b34d061c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN119ff7cc-5a38-490a-a982-7431b34d061c1
310431gabapentin 300 MG Oral CapsuleSCD119ff7cc-5a38-490a-a982-7431b34d061c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-347-304586503473030 in 1 BOTTLEHistorical
45865-347-4945865034749100 in 1 BOTTLEHistorical
45865-347-5745865034757180 in 1 BOTTLEHistorical
45865-347-604586503476060 in 1 BOTTLEHistorical
45865-347-904586503479090 in 1 BOTTLEHistorical