Gabapentin

Product NDC
53217-268
11-digit product format
532170268
Labeler code
53217
Product ID
53217-268_8f7996d0-00fe-4d22-bcd0-077f9c1898b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-268-022020-01-31C16284748780-19d75b9d0-29da-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 for oral use Initial U.S. Approval: 1993
53217-268-302020-01-31C16284748780-19d75b9d0-29da-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 for oral use Initial U.S. Approval: 1993
53217-268-602020-01-31C16284748780-19d75b9d0-29da-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 for oral use Initial U.S. Approval: 1993
53217-268-902020-01-31C16284748780-19d75b9d0-29da-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 for oral use Initial U.S. Approval: 1993
53217-268-992020-01-31C16284748780-19d75b9d0-29da-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 for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-268-02Gabapentin120 in 1 BOTTLECAPSULE1201
53217-268-30Gabapentin30 in 1 BOTTLECAPSULE301
53217-268-60Gabapentin60 in 1 BOTTLECAPSULE601
53217-268-90Gabapentin90 in 1 BOTTLECAPSULE901
53217-268-99Gabapentin180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-268-02EA - Each53217-268d3b51bb6-e33c-423a-80f6-85354dfaa14412017-05-03
53217-268-30EA - Each53217-26884212ef5-2a20-4e75-9e0e-99477d3ed05a12017-05-03
53217-268-60EA - Each53217-268404f1f88-53ba-45eb-9b2c-5b8d15b60b2212017-05-03
53217-268-90EA - Each53217-268fdb4c262-f3b4-4283-a7f5-e7aa9ee01fc712017-05-03
53217-268-99EA - Each53217-26805cce793-ca52-49c4-b94a-bf93f3c65f2112017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-268GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 5 package rows20170408_04a0c58c-dddf-462d-96e6-9317161ea496.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN04a0c58c-dddf-462d-96e6-9317161ea4961
310432gabapentin 400 MG Oral CapsuleSCD04a0c58c-dddf-462d-96e6-9317161ea4961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-268-0253217026802120 in 1 BOTTLEHistorical
53217-268-305321702683030 in 1 BOTTLEHistorical
53217-268-605321702686060 in 1 BOTTLEHistorical
53217-268-905321702689090 in 1 BOTTLEHistorical
53217-268-9953217026899180 in 1 BOTTLEHistorical