FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1197
11-digit product format
713351197
Labeler code
71335
Product ID
71335-1197_deb8124f-da8b-477e-97db-91c148237db2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

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
71335-1197-0Gabapentin20 in 1 BOTTLECAPSULE2010
71335-1197-1Gabapentin30 in 1 BOTTLECAPSULE3010
71335-1197-2Gabapentin90 in 1 BOTTLECAPSULE9010
71335-1197-3Gabapentin60 in 1 BOTTLECAPSULE6010
71335-1197-4Gabapentin120 in 1 BOTTLECAPSULE12010
71335-1197-5Gabapentin100 in 1 BOTTLECAPSULE10010
71335-1197-6Gabapentin28 in 1 BOTTLECAPSULE2810
71335-1197-7Gabapentin112 in 1 BOTTLECAPSULE11210
71335-1197-8Gabapentin84 in 1 BOTTLECAPSULE8410
71335-1197-9Gabapentin180 in 1 BOTTLECAPSULE18010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1197-1EA - Each71335-11970a5d4ae0-96a6-4a95-91ec-cb5c67ca5e1212019-09-05
71335-1197-2EA - Each71335-1197962ce2a8-f6fd-4427-b85c-0a5497d7e76912019-09-05
71335-1197-3EA - Each71335-1197bfb1ba1f-7618-4be5-8a2c-d34bd079b61c12019-09-05
71335-1197-4EA - Each71335-1197b74d9bbc-692a-4189-a86d-de91c6d8e25412019-09-05
71335-1197-5EA - Each71335-1197df6b2f3e-97a6-4ee1-b7d1-32b3176b8c7b12019-09-05
71335-1197-9EA - Each71335-1197c121da58-4f52-4bdc-8339-da8999c5e73a12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1197GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20250224_6a0a75ac-e121-477b-a9d1-d11f588afc9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN6a0a75ac-e121-477b-a9d1-d11f588afc9d10
310431gabapentin 300 MG Oral CapsuleSCD6a0a75ac-e121-477b-a9d1-d11f588afc9d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1197-07133511970020 CAPSULE in 1 BOTTLE (71335-1197-0) 20 capsule2021-08-240000-00-00NoNoCurrent
71335-1197-17133511970130 CAPSULE in 1 BOTTLE (71335-1197-1) 30 capsule2019-06-140000-00-00NoNoCurrent
71335-1197-27133511970290 CAPSULE in 1 BOTTLE (71335-1197-2) 90 capsule2019-05-070000-00-00NoNoCurrent
71335-1197-37133511970360 CAPSULE in 1 BOTTLE (71335-1197-3) 60 capsule2019-07-010000-00-00NoNoCurrent
71335-1197-471335119704120 CAPSULE in 1 BOTTLE (71335-1197-4) 120 capsule2019-07-150000-00-00NoNoCurrent
71335-1197-571335119705100 CAPSULE in 1 BOTTLE (71335-1197-5) 100 capsule2019-07-150000-00-00NoNoCurrent
71335-1197-67133511970628 CAPSULE in 1 BOTTLE (71335-1197-6) 28 capsule2025-01-290000-00-00NoNoCurrent
71335-1197-771335119707112 CAPSULE in 1 BOTTLE (71335-1197-7) 112 capsule2024-03-220000-00-00NoNoCurrent
71335-1197-87133511970884 CAPSULE in 1 BOTTLE (71335-1197-8) 84 capsule2025-01-290000-00-00NoNoCurrent
71335-1197-971335119709180 CAPSULE in 1 BOTTLE (71335-1197-9) 180 capsule2019-07-260000-00-00NoNoCurrent