Gabapentin

Product NDC
53217-282
11-digit product format
532170282
Labeler code
53217
Product ID
53217-282_bbe4b5f0-5923-4c54-ae1d-953d5eb2da2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
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
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
53217-282-022020-01-31C16284748780-19d75b9d0-5647-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
53217-282-302020-01-31C16284748780-19d75b9d0-5647-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
53217-282-452020-01-31C16284748780-19d75b9d0-5647-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
53217-282-602020-01-31C16284748780-19d75b9d0-5647-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
53217-282-902020-01-31C16284748780-19d75b9d0-5647-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
53217-282-972020-01-31C16284748780-19d75b9d0-5647-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
53217-282-02Gabapentin120 in 1 BOTTLETABLET1201
53217-282-30Gabapentin30 in 1 BOTTLETABLET301
53217-282-45Gabapentin45 in 1 BOTTLETABLET451
53217-282-60Gabapentin60 in 1 BOTTLETABLET601
53217-282-90Gabapentin90 in 1 BOTTLETABLET901
53217-282-97Gabapentin126 in 1 BOTTLETABLET1261

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-282-02EA - Each53217-282c2e9b637-08a2-4507-be72-caec8c341acb12017-05-04
53217-282-30EA - Each53217-2823e9aeed9-1bb1-40cd-aa83-00beb5b0754812017-05-04
53217-282-45EA - Each53217-282826eb0bc-49f6-43b2-8085-e781cc98a42b12017-05-04
53217-282-60EA - Each53217-282a9f3c441-88b1-4d2d-befb-f50754b01b4712017-05-04
53217-282-90EA - Each53217-282d006d8e2-01ff-4d88-8822-079e449701e212017-05-04
53217-282-97EA - Each53217-2822a5a3dd7-a568-4f26-8f3c-686d1ec807db12017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-282GABAPENTIN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20170422_3aa67116-d8fa-4fb1-8293-721a4574e419.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN3aa67116-d8fa-4fb1-8293-721a4574e4191
310433gabapentin 600 MG Oral TabletSCD3aa67116-d8fa-4fb1-8293-721a4574e4191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-282-0253217028202120 in 1 BOTTLEHistorical
53217-282-305321702823030 in 1 BOTTLEHistorical
53217-282-455321702824545 in 1 BOTTLEHistorical
53217-282-605321702826060 in 1 BOTTLEHistorical
53217-282-905321702829090 in 1 BOTTLEHistorical
53217-282-9753217028297126 in 1 BOTTLEHistorical