FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1132
11-digit product format
713351132
Labeler code
71335
Product ID
71335-1132_b600479a-315e-47e3-9c50-bfaab1d5c12c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
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
71335-1132-0Gabapentin28 in 1 BOTTLETABLET, FILM COATED28102
71335-1132-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED30102
71335-1132-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED60102
71335-1132-3Gabapentin180 in 1 BOTTLETABLET, FILM COATED180102
71335-1132-4Gabapentin90 in 1 BOTTLETABLET, FILM COATED90102
71335-1132-5Gabapentin100 in 1 BOTTLETABLET, FILM COATED100102
71335-1132-6Gabapentin120 in 1 BOTTLETABLET, FILM COATED120102
71335-1132-7Gabapentin500 in 1 BOTTLETABLET, FILM COATED500102
71335-1132-8Gabapentin84 in 1 BOTTLETABLET, FILM COATED84102
71335-1132-9Gabapentin112 in 1 BOTTLETABLET, FILM COATED112102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1132-1EA - Each71335-11324521b8b7-166a-4582-b539-32757a6c73c812020-07-13
71335-1132-2EA - Each71335-1132bf44db25-17c1-442d-ae59-d390dfd5deed12019-11-12
71335-1132-4EA - Each71335-113297a58c72-ab97-4fe0-b115-87029133573312020-03-10
71335-1132-6EA - Each71335-1132c19c7478-b29b-4a56-b88a-463c6d113a2b12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1132GABAPENTIN TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240406_c9944562-563a-423d-972c-f0313375d234.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNc9944562-563a-423d-972c-f0313375d234102
310433gabapentin 600 MG Oral TabletSCDc9944562-563a-423d-972c-f0313375d234102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1132-07133511320028 TABLET, FILM COATED in 1 BOTTLE (71335-1132-0) 2024-04-020000-00-00NoNoCurrent
71335-1132-17133511320130 TABLET, FILM COATED in 1 BOTTLE (71335-1132-1) 2019-09-180000-00-00NoNoCurrent
71335-1132-27133511320260 TABLET, FILM COATED in 1 BOTTLE (71335-1132-2) 2019-03-220000-00-00NoNoCurrent
71335-1132-371335113203180 TABLET, FILM COATED in 1 BOTTLE (71335-1132-3) 2020-03-240000-00-00NoNoCurrent
71335-1132-47133511320490 TABLET, FILM COATED in 1 BOTTLE (71335-1132-4) 2019-03-210000-00-00NoNoCurrent
71335-1132-571335113205100 TABLET, FILM COATED in 1 BOTTLE (71335-1132-5) 2024-04-020000-00-00NoNoCurrent
71335-1132-671335113206120 TABLET, FILM COATED in 1 BOTTLE (71335-1132-6) 2019-04-050000-00-00NoNoCurrent
71335-1132-771335113207500 TABLET, FILM COATED in 1 BOTTLE (71335-1132-7) 2024-04-020000-00-00NoNoCurrent
71335-1132-87133511320884 TABLET, FILM COATED in 1 BOTTLE (71335-1132-8) 2024-04-020000-00-00NoNoCurrent
71335-1132-971335113209112 TABLET, FILM COATED in 1 BOTTLE (71335-1132-9) 2024-04-020000-00-00NoNoCurrent