FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1198
11-digit product format
713351198
Labeler code
71335
Product ID
71335-1198_9cc03b39-2b1a-40c9-90d8-f3a59c805f16
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
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1198-0Gabapentin65 in 1 BOTTLECAPSULE65106
71335-1198-1Gabapentin56 in 1 BOTTLECAPSULE56106
71335-1198-2Gabapentin90 in 1 BOTTLECAPSULE90106
71335-1198-3Gabapentin30 in 1 BOTTLECAPSULE30106
71335-1198-4Gabapentin60 in 1 BOTTLECAPSULE60106
71335-1198-5Gabapentin28 in 1 BOTTLECAPSULE28106
71335-1198-6Gabapentin360 in 1 BOTTLECAPSULE360106
71335-1198-7Gabapentin120 in 1 BOTTLECAPSULE120106
71335-1198-8Gabapentin100 in 1 BOTTLECAPSULE100106
71335-1198-9Gabapentin84 in 1 BOTTLECAPSULE84106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1198-2EA - Each71335-11981d1791e8-023c-4523-8289-ed1d9dcc92e312023-12-05
71335-1198-3EA - Each71335-119858e49cab-eef4-46c2-9bdf-c7a24155d77112023-12-05
71335-1198-4EA - Each71335-1198148a1a2a-362c-483f-b34a-11317041e38c12019-12-10
71335-1198-7EA - Each71335-11981dba5732-8489-4ea0-8e83-f934a8e868da12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1198GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 10 package rows20250224_8a781649-3271-47a6-995f-50f91141a48a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN8a781649-3271-47a6-995f-50f91141a48a106
310430gabapentin 100 MG Oral CapsuleSCD8a781649-3271-47a6-995f-50f91141a48a106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1198-07133511980065 CAPSULE in 1 BOTTLE (71335-1198-0) 65 capsule2025-01-290000-00-00NoNoCurrent
71335-1198-17133511980156 CAPSULE in 1 BOTTLE (71335-1198-1) 56 capsule2025-01-290000-00-00NoNoCurrent
71335-1198-27133511980290 CAPSULE in 1 BOTTLE (71335-1198-2) 90 capsule2019-05-140000-00-00NoNoCurrent
71335-1198-37133511980330 CAPSULE in 1 BOTTLE (71335-1198-3) 30 capsule2019-05-130000-00-00NoNoCurrent
71335-1198-47133511980460 CAPSULE in 1 BOTTLE (71335-1198-4) 60 capsule2019-05-030000-00-00NoNoCurrent
71335-1198-57133511980528 CAPSULE in 1 BOTTLE (71335-1198-5) 28 capsule2025-01-290000-00-00NoNoCurrent
71335-1198-671335119806360 CAPSULE in 1 BOTTLE (71335-1198-6) 360 capsule2025-01-290000-00-00NoNoCurrent
71335-1198-771335119807120 CAPSULE in 1 BOTTLE (71335-1198-7) 120 capsule2019-05-150000-00-00NoNoCurrent
71335-1198-871335119808100 CAPSULE in 1 BOTTLE (71335-1198-8) 100 capsule2020-06-220000-00-00NoNoCurrent
71335-1198-97133511980984 CAPSULE in 1 BOTTLE (71335-1198-9) 84 capsule2025-01-290000-00-00NoNoCurrent