FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-0214
11-digit product format
713350214
Labeler code
71335
Product ID
71335-0214_4cc80fe1-3631-4b57-8efa-9fe9e56cf509
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310432

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
71335-0214-02024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-12024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-22024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-32024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-42024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-52024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-62024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-72024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-82024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-92024-05-17C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-02024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-12024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-22024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-32024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-42024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-52024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-62024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-72024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-82024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-92024-01-30C16284748780-11030e365-6ef1-111a-e063-dadaa90a10e2These 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
71335-0214-0Gabapentin180 in 1 BOTTLECAPSULE1807
71335-0214-1Gabapentin20 in 1 BOTTLECAPSULE207
71335-0214-2Gabapentin90 in 1 BOTTLECAPSULE907
71335-0214-3Gabapentin60 in 1 BOTTLECAPSULE607
71335-0214-4Gabapentin30 in 1 BOTTLECAPSULE307
71335-0214-5Gabapentin120 in 1 BOTTLECAPSULE1207
71335-0214-6Gabapentin21 in 1 BOTTLECAPSULE217
71335-0214-7Gabapentin84 in 1 BOTTLECAPSULE847
71335-0214-8Gabapentin112 in 1 BOTTLECAPSULE1127
71335-0214-9Gabapentin28 in 1 BOTTLECAPSULE287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0214-0EA - Each71335-02141a98cc5b-aa82-4cef-9980-9f71b639e44412018-03-08
71335-0214-1EA - Each71335-0214257ca1cd-2822-492f-adb4-2976c82fe84112018-03-08
71335-0214-2EA - Each71335-02149477a62f-9e01-4aa4-977b-9178fef79ddf12018-01-12
71335-0214-3EA - Each71335-02145819115b-8e8d-4c29-b0fd-a46870a3236512018-01-12
71335-0214-4EA - Each71335-0214a7264727-74a5-495d-8fc1-011186b4815712018-01-12
71335-0214-5EA - Each71335-0214d76e3716-3b50-4c7f-ba4b-5b5e5c45586212018-01-12
71335-0214-6EA - Each71335-0214862d5379-1bd0-4533-be4a-e945370b27f012018-01-12
71335-0214-7EA - Each71335-02142761400f-afae-4e42-999e-ad8632a5e6df12018-01-12
71335-0214-8EA - Each71335-0214760e44fd-86c1-4250-add0-5e68ece9c06212018-01-12
71335-0214-9EA - Each71335-0214da2f59c6-23e9-4c31-93cf-006ced77988c12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0214GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20241109_657349fb-41a9-4814-b4ac-4c5afbdde947.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN657349fb-41a9-4814-b4ac-4c5afbdde9477
310432gabapentin 400 MG Oral CapsuleSCD657349fb-41a9-4814-b4ac-4c5afbdde9477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0214-071335021400180 CAPSULE in 1 BOTTLE (71335-0214-0) 180 capsule2024-10-300000-00-00NoNoCurrent
71335-0214-17133502140120 CAPSULE in 1 BOTTLE (71335-0214-1) 20 capsule2024-10-300000-00-00NoNoCurrent
71335-0214-27133502140290 CAPSULE in 1 BOTTLE (71335-0214-2) 90 capsule2018-04-110000-00-00NoNoCurrent
71335-0214-37133502140360 CAPSULE in 1 BOTTLE (71335-0214-3) 60 capsule2018-06-040000-00-00NoNoCurrent
71335-0214-47133502140430 CAPSULE in 1 BOTTLE (71335-0214-4) 30 capsule2018-07-030000-00-00NoNoCurrent
71335-0214-571335021405120 CAPSULE in 1 BOTTLE (71335-0214-5) 120 capsule2018-08-270000-00-00NoNoCurrent
71335-0214-67133502140621 CAPSULE in 1 BOTTLE (71335-0214-6) 21 capsule2024-10-300000-00-00NoNoCurrent
71335-0214-77133502140784 CAPSULE in 1 BOTTLE (71335-0214-7) 84 capsule2024-10-300000-00-00NoNoCurrent
71335-0214-871335021408112 CAPSULE in 1 BOTTLE (71335-0214-8) 112 capsule2024-10-300000-00-00NoNoCurrent
71335-0214-97133502140928 CAPSULE in 1 BOTTLE (71335-0214-9) 28 capsule2024-10-300000-00-00NoNoCurrent