FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2748
11-digit product format
713352748
Labeler code
71335
Product ID
71335-2748_66e2ab40-8eed-4798-be0c-bce1dadf6164
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
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
71335-2748-1Gabapentin90 in 1 BOTTLECAPSULE901
71335-2748-2Gabapentin28 in 1 BOTTLECAPSULE281
71335-2748-3Gabapentin58 in 1 BOTTLECAPSULE581
71335-2748-4Gabapentin30 in 1 BOTTLECAPSULE301
71335-2748-5Gabapentin60 in 1 BOTTLECAPSULE601
71335-2748-6Gabapentin120 in 1 BOTTLECAPSULE1201
71335-2748-7Gabapentin180 in 1 BOTTLECAPSULE1801
71335-2748-8Gabapentin40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2748-1EA - Each71335-2748b27843cd-2732-4fa0-99c0-99ddcf076c8712026-04-20
71335-2748-2EA - Each71335-2748ea935d1d-4466-403a-8932-a9d755b1c56f12026-04-20
71335-2748-3EA - Each71335-2748ce27eb0e-9b2c-446c-9b93-70aa1536a34e12026-04-20
71335-2748-4EA - Each71335-27484a14dfb6-9968-433b-bb32-10c5e9c6baf812026-04-20
71335-2748-5EA - Each71335-2748a7ee4cea-eca9-435c-ac1b-485bbd3641dd12026-04-20
71335-2748-6EA - Each71335-2748f352c4a0-bdeb-4287-b27e-181d9461c00812026-04-20
71335-2748-7EA - Each71335-2748ab83c8c7-5688-4734-aede-98b72902b1e312026-04-20
71335-2748-8EA - Each71335-27487b5aa629-902b-4be1-a1de-ddef0fe8f6e612026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNeaf5e41e-8ed3-404e-84e0-392bebdbc0b71
310431gabapentin 300 MG Oral CapsuleSCDeaf5e41e-8ed3-404e-84e0-392bebdbc0b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2748-17133527480190 CAPSULE in 1 BOTTLE (71335-2748-1) 90 capsule2025-10-03NoNoHistorical
71335-2748-27133527480228 CAPSULE in 1 BOTTLE (71335-2748-2) 28 capsule2025-10-03NoNoHistorical
71335-2748-37133527480358 CAPSULE in 1 BOTTLE (71335-2748-3) 58 capsule2025-10-03NoNoHistorical
71335-2748-47133527480430 CAPSULE in 1 BOTTLE (71335-2748-4) 30 capsule2025-10-03NoNoHistorical
71335-2748-57133527480560 CAPSULE in 1 BOTTLE (71335-2748-5) 60 capsule2025-10-03NoNoHistorical
71335-2748-671335274806120 CAPSULE in 1 BOTTLE (71335-2748-6) 120 capsule2025-10-03NoNoHistorical
71335-2748-771335274807180 CAPSULE in 1 BOTTLE (71335-2748-7) 180 capsule2025-10-03NoNoHistorical
71335-2748-87133527480840 CAPSULE in 1 BOTTLE (71335-2748-8) 40 capsule2025-10-03NoNoHistorical