FDA.reportPublic FDA data

GABAPENTIN

Product NDC
53217-241
11-digit product format
532170241
Labeler code
53217
Product ID
53217-241_259fd673-2e54-4046-a362-7c186dc8f735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090705
Marketing category
ANDA
Marketing start
2016-06-29
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
No
Listing certified through
2019-12-31
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
53217-241-002020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993
53217-241-022020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993
53217-241-152020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993
53217-241-222020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993
53217-241-302020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993
53217-241-452020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993
53217-241-602020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993
53217-241-902020-01-31C16284748780-19d75b9d1-1149-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. GABAPENTIN Capsules, USP for oral use, Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-241-00GABAPENTIN100 in 1 BOTTLECAPSULE1003
53217-241-02GABAPENTIN120 in 1 BOTTLECAPSULE1203
53217-241-15GABAPENTIN15 in 1 BOTTLECAPSULE153
53217-241-22GABAPENTIN270 in 1 BOTTLECAPSULE2703
53217-241-30GABAPENTIN30 in 1 BOTTLECAPSULE303
53217-241-45GABAPENTIN45 in 1 BOTTLECAPSULE453
53217-241-60GABAPENTIN60 in 1 BOTTLECAPSULE603
53217-241-90GABAPENTIN90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-241-00EA - Each53217-241d39028dd-8c13-49d3-8232-3df44c975c7e12016-12-07
53217-241-02EA - Each53217-241e68c4ee9-5bc3-4788-a6bf-5c505a5c737c12016-12-07
53217-241-15EA - Each53217-241409160aa-a253-48f1-b4e0-a7bc5e8bd0c912016-12-07
53217-241-22EA - Each53217-2410dbd4628-d1ec-4987-af67-e4a86bae3d9712016-12-07
53217-241-30EA - Each53217-2411c122c75-8533-4df3-a483-07e279562aa212016-12-07
53217-241-45EA - Each53217-241ade7ce17-4709-4593-a9f1-2d271623d3fe12016-12-07
53217-241-60EA - Each53217-241d9544933-696c-4cdd-9894-cd3968ee830b12016-12-07
53217-241-90EA - Each53217-241954a1495-02bf-4755-8832-98d3f78a4bca12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-241GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 8 package rows20161201_828cb73e-536a-48db-acf3-52e36b7e8c53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN828cb73e-536a-48db-acf3-52e36b7e8c533
310430gabapentin 100 MG Oral CapsuleSCD828cb73e-536a-48db-acf3-52e36b7e8c533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-241-0053217024100100 in 1 BOTTLEHistorical
53217-241-0253217024102120 in 1 BOTTLEHistorical
53217-241-155321702411515 in 1 BOTTLEHistorical
53217-241-2253217024122270 in 1 BOTTLEHistorical
53217-241-305321702413030 in 1 BOTTLEHistorical
53217-241-455321702414545 in 1 BOTTLEHistorical
53217-241-605321702416060 in 1 BOTTLEHistorical
53217-241-905321702419090 in 1 BOTTLEHistorical