FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1200
11-digit product format
713351200
Labeler code
71335
Product ID
71335-1200_4be0d60b-e4d2-484b-a870-6fdc3893f5f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206402
Marketing category
ANDA
Marketing start
2015-11-01
Substance
GABAPENTIN
Active strength
600 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
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
71335-1200-0Gabapentin28 in 1 BOTTLETABLET2813
71335-1200-1Gabapentin30 in 1 BOTTLETABLET3013
71335-1200-2Gabapentin60 in 1 BOTTLETABLET6013
71335-1200-3Gabapentin180 in 1 BOTTLETABLET18013
71335-1200-4Gabapentin90 in 1 BOTTLETABLET9013
71335-1200-5Gabapentin100 in 1 BOTTLETABLET10013
71335-1200-6Gabapentin120 in 1 BOTTLETABLET12013
71335-1200-7Gabapentin500 in 1 BOTTLETABLET50013
71335-1200-8Gabapentin84 in 1 BOTTLETABLET8413
71335-1200-9Gabapentin112 in 1 BOTTLETABLET11213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1200-1EA - Each71335-12000b3672dc-c7dc-4b47-bec5-1996f86d876c12019-11-12
71335-1200-2EA - Each71335-1200d8674e55-eeda-4f4c-8e41-2ad538f4fb8f12023-12-05
71335-1200-3EA - Each71335-1200a18d0c14-d659-4732-9e90-a9a76961a23012024-11-05
71335-1200-4EA - Each71335-12000cd52e26-ae40-4d60-8667-08d4daf964e812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1200GABAPENTIN TABLET [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 10 package rows20250224_a1ff94a9-69c4-486a-aab2-563c7ed244c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNa1ff94a9-69c4-486a-aab2-563c7ed244c813
310433gabapentin 600 MG Oral TabletSCDa1ff94a9-69c4-486a-aab2-563c7ed244c813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1200-07133512000028 TABLET in 1 BOTTLE (71335-1200-0) 28 tablet2025-01-300000-00-00NoNoCurrent
71335-1200-17133512000130 TABLET in 1 BOTTLE (71335-1200-1) 30 tablet2019-05-060000-00-00NoNoCurrent
71335-1200-27133512000260 TABLET in 1 BOTTLE (71335-1200-2) 60 tablet2019-05-130000-00-00NoNoCurrent
71335-1200-371335120003180 TABLET in 1 BOTTLE (71335-1200-3) 180 tablet2019-06-120000-00-00NoNoCurrent
71335-1200-47133512000490 TABLET in 1 BOTTLE (71335-1200-4) 90 tablet2019-04-220000-00-00NoNoCurrent
71335-1200-571335120005100 TABLET in 1 BOTTLE (71335-1200-5) 100 tablet2025-01-300000-00-00NoNoCurrent
71335-1200-671335120006120 TABLET in 1 BOTTLE (71335-1200-6) 120 tablet2019-05-020000-00-00NoNoCurrent
71335-1200-771335120007500 TABLET in 1 BOTTLE (71335-1200-7) 500 tablet2025-01-300000-00-00NoNoCurrent
71335-1200-87133512000884 TABLET in 1 BOTTLE (71335-1200-8) 84 tablet2025-01-300000-00-00NoNoCurrent
71335-1200-971335120009112 TABLET in 1 BOTTLE (71335-1200-9) 112 tablet2025-01-300000-00-00NoNoCurrent