FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2037
11-digit product format
713352037
Labeler code
71335
Product ID
71335-2037_f31172a2-0ae9-49f2-b797-b26fe33f3f64
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
800 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
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2037-1Gabapentin30 in 1 BOTTLETABLET30107
71335-2037-2Gabapentin60 in 1 BOTTLETABLET60107
71335-2037-3Gabapentin90 in 1 BOTTLETABLET90107
71335-2037-4Gabapentin180 in 1 BOTTLETABLET180107
71335-2037-5Gabapentin120 in 1 BOTTLETABLET120107
71335-2037-6Gabapentin100 in 1 BOTTLETABLET100107
71335-2037-7Gabapentin84 in 1 BOTTLETABLET84107
71335-2037-8Gabapentin112 in 1 BOTTLETABLET112107
71335-2037-9Gabapentin135 in 1 BOTTLETABLET135107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2037-2EA - Each71335-20379ab6607e-ca35-4c44-92b3-f2d92e2d065112023-09-05
71335-2037-3EA - Each71335-2037ee50a4c6-29a3-4454-b754-b4fc1c032e8912023-02-06
71335-2037-5EA - Each71335-2037453c4309-9c65-4f3f-8c51-66e09e73132c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2037GABAPENTIN TABLET [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 9 package rows20250226_f31172a2-0ae9-49f2-b797-b26fe33f3f64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNf31172a2-0ae9-49f2-b797-b26fe33f3f64107
310434gabapentin 800 MG Oral TabletSCDf31172a2-0ae9-49f2-b797-b26fe33f3f64107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2037-17133520370130 TABLET in 1 BOTTLE (71335-2037-1) 30 tablet2022-04-130000-00-00NoNoCurrent
71335-2037-27133520370260 TABLET in 1 BOTTLE (71335-2037-2) 60 tablet2022-03-070000-00-00NoNoCurrent
71335-2037-37133520370390 TABLET in 1 BOTTLE (71335-2037-3) 90 tablet2022-03-070000-00-00NoNoCurrent
71335-2037-471335203704180 TABLET in 1 BOTTLE (71335-2037-4) 180 tablet2025-01-300000-00-00NoNoCurrent
71335-2037-571335203705120 TABLET in 1 BOTTLE (71335-2037-5) 120 tablet2022-03-140000-00-00NoNoCurrent
71335-2037-671335203706100 TABLET in 1 BOTTLE (71335-2037-6) 100 tablet2025-01-300000-00-00NoNoCurrent
71335-2037-77133520370784 TABLET in 1 BOTTLE (71335-2037-7) 84 tablet2025-01-300000-00-00NoNoCurrent
71335-2037-871335203708112 TABLET in 1 BOTTLE (71335-2037-8) 112 tablet2025-01-300000-00-00NoNoCurrent
71335-2037-971335203709135 TABLET in 1 BOTTLE (71335-2037-9) 135 tablet2025-01-300000-00-00NoNoCurrent