FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71335-3057
11-digit product format
713353057
Labeler code
71335
Product ID
71335-3057_6af55316-950c-402a-b479-4fdf6bc662cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3057-1GABAPENTIN30 in 1 BOTTLETABLET301
71335-3057-2GABAPENTIN60 in 1 BOTTLETABLET601
71335-3057-3GABAPENTIN90 in 1 BOTTLETABLET901
71335-3057-4GABAPENTIN180 in 1 BOTTLETABLET1801
71335-3057-5GABAPENTIN120 in 1 BOTTLETABLET1201
71335-3057-6GABAPENTIN100 in 1 BOTTLETABLET1001
71335-3057-7GABAPENTIN84 in 1 BOTTLETABLET841
71335-3057-8GABAPENTIN112 in 1 BOTTLETABLET1121
71335-3057-9GABAPENTIN135 in 1 BOTTLETABLET1351

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3057-1EA - Each71335-3057bb76fa73-148e-478b-beef-7ad06f98a96412026-03-17
71335-3057-2EA - Each71335-3057c88bd8a4-cfe3-4c76-ae1b-e7d1a07c7d5712026-03-17
71335-3057-3EA - Each71335-3057704ea3b5-95ec-4241-853a-19f886b1053a12026-03-17
71335-3057-4EA - Each71335-305764b160ae-b582-44d6-ba3b-8b4be86852b112026-03-17
71335-3057-5EA - Each71335-3057d1d6ddfe-80f5-424b-a5bc-b105ca6129c212026-03-17
71335-3057-6EA - Each71335-30573175906f-cbc6-4f33-9293-7863e233de0c12026-03-17
71335-3057-7EA - Each71335-3057b291552c-e9b5-4fec-9c8b-952a65b6f43512026-03-17
71335-3057-8EA - Each71335-30571311ad37-cf04-45b5-8135-c2d98566f2a612026-03-17
71335-3057-9EA - Each71335-30577cdb228d-5dbb-40d9-b9f7-8eb158cdb34812026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN2e331641-ec26-4d76-b16b-a9863c767afe1
310434gabapentin 800 MG Oral TabletSCD2e331641-ec26-4d76-b16b-a9863c767afe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3057-17133530570130 TABLET in 1 BOTTLE (71335-3057-1) 30 tablet2026-02-06NoNoHistorical
71335-3057-27133530570260 TABLET in 1 BOTTLE (71335-3057-2) 60 tablet2026-02-06NoNoHistorical
71335-3057-37133530570390 TABLET in 1 BOTTLE (71335-3057-3) 90 tablet2026-02-06NoNoHistorical
71335-3057-471335305704180 TABLET in 1 BOTTLE (71335-3057-4) 180 tablet2026-02-06NoNoHistorical
71335-3057-571335305705120 TABLET in 1 BOTTLE (71335-3057-5) 120 tablet2026-02-06NoNoHistorical
71335-3057-671335305706100 TABLET in 1 BOTTLE (71335-3057-6) 100 tablet2026-02-06NoNoHistorical
71335-3057-77133530570784 TABLET in 1 BOTTLE (71335-3057-7) 84 tablet2026-02-06NoNoHistorical
71335-3057-871335305708112 TABLET in 1 BOTTLE (71335-3057-8) 112 tablet2026-02-06NoNoHistorical
71335-3057-971335305709135 TABLET in 1 BOTTLE (71335-3057-9) 135 tablet2026-02-06NoNoHistorical