FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-3060
11-digit product format
713353060
Labeler code
71335
Product ID
71335-3060_5d28b44b-1f62-4868-8345-acdf1df41481
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217995
Marketing category
ANDA
Marketing start
2024-04-04
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3060-0Gabapentin28 in 1 BOTTLETABLET281
71335-3060-1Gabapentin30 in 1 BOTTLETABLET301
71335-3060-2Gabapentin60 in 1 BOTTLETABLET601
71335-3060-3Gabapentin180 in 1 BOTTLETABLET1801
71335-3060-4Gabapentin90 in 1 BOTTLETABLET901
71335-3060-5Gabapentin100 in 1 BOTTLETABLET1001
71335-3060-6Gabapentin120 in 1 BOTTLETABLET1201
71335-3060-7Gabapentin500 in 1 BOTTLETABLET5001
71335-3060-8Gabapentin84 in 1 BOTTLETABLET841
71335-3060-9Gabapentin112 in 1 BOTTLETABLET1121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3060-1EA - Each71335-306093cebbae-7057-4f0b-83d4-303f3001c07312026-03-17
71335-3060-2EA - Each71335-3060fae725ef-a646-45a5-9060-b1c52169896112026-03-17
71335-3060-3EA - Each71335-306060abb833-fe8f-445d-9368-470b0537e8e412026-03-17
71335-3060-4EA - Each71335-3060ad11bee6-9b91-4af2-b25c-219192fd100412026-03-17
71335-3060-6EA - Each71335-3060cebe9191-a99a-4cc0-a28f-bbeb543c620712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNcc1998a7-7004-4688-8b5b-525041851d1d1
310433gabapentin 600 MG Oral TabletSCDcc1998a7-7004-4688-8b5b-525041851d1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3060-07133530600028 TABLET in 1 BOTTLE (71335-3060-0) 28 tablet2026-02-05NoNoHistorical
71335-3060-17133530600130 TABLET in 1 BOTTLE (71335-3060-1) 30 tablet2026-02-05NoNoHistorical
71335-3060-27133530600260 TABLET in 1 BOTTLE (71335-3060-2) 60 tablet2026-02-05NoNoHistorical
71335-3060-371335306003180 TABLET in 1 BOTTLE (71335-3060-3) 180 tablet2026-02-05NoNoHistorical
71335-3060-47133530600490 TABLET in 1 BOTTLE (71335-3060-4) 90 tablet2026-02-05NoNoHistorical
71335-3060-571335306005100 TABLET in 1 BOTTLE (71335-3060-5) 100 tablet2026-02-05NoNoHistorical
71335-3060-671335306006120 TABLET in 1 BOTTLE (71335-3060-6) 120 tablet2026-02-05NoNoHistorical
71335-3060-771335306007500 TABLET in 1 BOTTLE (71335-3060-7) 500 tablet2026-02-05NoNoHistorical
71335-3060-87133530600884 TABLET in 1 BOTTLE (71335-3060-8) 84 tablet2026-02-05NoNoHistorical
71335-3060-971335306009112 TABLET in 1 BOTTLE (71335-3060-9) 112 tablet2026-02-05NoNoHistorical