Gabapentin

Product NDC
53217-284
11-digit product format
532170284
Labeler code
53217
Product ID
53217-284_041af629-e2da-4269-b675-7766fc40b51d
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
300 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-284-002020-01-31C16284748780-19d75b9d1-0615-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
53217-284-022020-01-31C16284748780-19d75b9d1-0615-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
53217-284-152020-01-31C16284748780-19d75b9d1-0615-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
53217-284-212020-01-31C16284748780-19d75b9d1-0615-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
53217-284-222020-01-31C16284748780-19d75b9d1-0615-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
53217-284-302020-01-31C16284748780-19d75b9d1-0615-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
53217-284-422020-01-31C16284748780-19d75b9d1-0615-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
53217-284-452020-01-31C16284748780-19d75b9d1-0615-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
53217-284-602020-01-31C16284748780-19d75b9d1-0615-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
53217-284-812020-01-31C16284748780-19d75b9d1-0615-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
53217-284-902020-01-31C16284748780-19d75b9d1-0615-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
53217-284-992020-01-31C16284748780-19d75b9d1-0615-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
53217-284-00Gabapentin100 in 1 BOTTLECAPSULE1001
53217-284-02Gabapentin120 in 1 BOTTLECAPSULE1201
53217-284-15Gabapentin15 in 1 BOTTLECAPSULE151
53217-284-21Gabapentin21 in 1 BOTTLECAPSULE211
53217-284-22Gabapentin270 in 1 BOTTLECAPSULE2701
53217-284-30Gabapentin30 in 1 BOTTLECAPSULE301
53217-284-42Gabapentin42 in 1 BOTTLECAPSULE421
53217-284-45Gabapentin45 in 1 BOTTLECAPSULE451
53217-284-60Gabapentin60 in 1 BOTTLECAPSULE601
53217-284-81Gabapentin81 in 1 BOTTLECAPSULE811
53217-284-90Gabapentin90 in 1 BOTTLECAPSULE901
53217-284-99Gabapentin180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-284-00EA - Each53217-284bbaca836-488f-4d2a-b7a7-3869bcf0a50712017-06-15
53217-284-02EA - Each53217-2848b3d56bc-58b4-43de-90c3-71a24661488b12017-06-15
53217-284-15EA - Each53217-284bc4f3564-3441-4f46-bfb1-8b3b3b94b7d312017-06-15
53217-284-21EA - Each53217-28495ee2647-bd4e-4877-9a5d-6c3f4c792f0d12017-06-15
53217-284-22EA - Each53217-2846b26b4bf-767c-416f-928f-948ccfa4163012017-06-15
53217-284-30EA - Each53217-28484751738-42ae-49b0-bc56-eca1e0548ab912017-06-15
53217-284-42EA - Each53217-28424fd71ef-ad99-45ca-a47c-025777faf9f712017-06-15
53217-284-45EA - Each53217-284fd47bcff-2e47-4cc7-9349-457e21c4f28912017-06-15
53217-284-60EA - Each53217-2849fcc3ffc-35f5-46d6-9898-958a0055d9ad12017-06-15
53217-284-81EA - Each53217-28443d35c07-8baf-4b60-a666-74b0c53798aa12017-06-15
53217-284-90EA - Each53217-28478ea4dab-d898-469e-8cd8-71c9c05be53b12017-06-15
53217-284-99EA - Each53217-2844005278c-e086-4460-97c9-9eedb813e6b612017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-284GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 12 package rows20170422_633e0bbe-579d-40c6-9347-d357291708e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN633e0bbe-579d-40c6-9347-d357291708e01
310431gabapentin 300 MG Oral CapsuleSCD633e0bbe-579d-40c6-9347-d357291708e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-284-0053217028400100 in 1 BOTTLEHistorical
53217-284-0253217028402120 in 1 BOTTLEHistorical
53217-284-155321702841515 in 1 BOTTLEHistorical
53217-284-215321702842121 in 1 BOTTLEHistorical
53217-284-2253217028422270 in 1 BOTTLEHistorical
53217-284-305321702843030 in 1 BOTTLEHistorical
53217-284-425321702844242 in 1 BOTTLEHistorical
53217-284-455321702844545 in 1 BOTTLEHistorical
53217-284-605321702846060 in 1 BOTTLEHistorical
53217-284-815321702848181 in 1 BOTTLEHistorical
53217-284-905321702849090 in 1 BOTTLEHistorical
53217-284-9953217028499180 in 1 BOTTLEHistorical