FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1375
11-digit product format
713351375
Labeler code
71335
Product ID
71335-1375_017348ea-f17f-40e2-8346-6607e34ed94a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1375-1Gabapentin90 in 1 BOTTLECAPSULE90102
71335-1375-2Gabapentin28 in 1 BOTTLECAPSULE28102
71335-1375-3Gabapentin30 in 1 BOTTLECAPSULE30102
71335-1375-4Gabapentin60 in 1 BOTTLECAPSULE60102
71335-1375-5Gabapentin120 in 1 BOTTLECAPSULE120102
71335-1375-6Gabapentin84 in 1 BOTTLECAPSULE84102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1375-3EA - Each71335-1375f42862b3-032b-44fb-8346-3812bbe8cf9a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1375GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240410_38210141-bbdc-4186-b71f-54c72f794dca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN38210141-bbdc-4186-b71f-54c72f794dca102
310430gabapentin 100 MG Oral CapsuleSCD38210141-bbdc-4186-b71f-54c72f794dca102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1375-17133513750190 CAPSULE in 1 BOTTLE (71335-1375-1) 90 capsule2019-12-060000-00-00NoNoCurrent
71335-1375-27133513750228 CAPSULE in 1 BOTTLE (71335-1375-2) 28 capsule2024-04-030000-00-00NoNoCurrent
71335-1375-37133513750330 CAPSULE in 1 BOTTLE (71335-1375-3) 30 capsule2019-10-230000-00-00NoNoCurrent
71335-1375-47133513750460 CAPSULE in 1 BOTTLE (71335-1375-4) 60 capsule2020-01-150000-00-00NoNoCurrent
71335-1375-571335137505120 CAPSULE in 1 BOTTLE (71335-1375-5) 120 capsule2020-01-070000-00-00NoNoCurrent
71335-1375-67133513750684 CAPSULE in 1 BOTTLE (71335-1375-6) 84 capsule2020-08-200000-00-00NoNoCurrent