FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1269
11-digit product format
713351269
Labeler code
71335
Product ID
71335-1269_6a0627fe-0cbc-4e93-928c-2d4d181b95e0
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
71335-1269-1Gabapentin90 in 1 BOTTLECAPSULE9010
71335-1269-2Gabapentin28 in 1 BOTTLECAPSULE2810
71335-1269-3Gabapentin58 in 1 BOTTLECAPSULE5810
71335-1269-4Gabapentin30 in 1 BOTTLECAPSULE3010
71335-1269-5Gabapentin60 in 1 BOTTLECAPSULE6010
71335-1269-6Gabapentin120 in 1 BOTTLECAPSULE12010
71335-1269-7Gabapentin180 in 1 BOTTLECAPSULE18010
71335-1269-8Gabapentin40 in 1 BOTTLECAPSULE4010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1269-1EA - Each71335-1269371654d8-e3da-4eb9-941f-a3aac6d5f9db12022-09-12
71335-1269-4EA - Each71335-1269a2222784-7e12-42ea-a3f0-8fcd17cf0f9212020-03-10
71335-1269-5EA - Each71335-12695a4739a1-6175-4f69-88aa-072967384ac012025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1269GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 8 package rows20250224_6670a64f-7f58-479f-b285-394abb753e2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN6670a64f-7f58-479f-b285-394abb753e2e10
310431gabapentin 300 MG Oral CapsuleSCD6670a64f-7f58-479f-b285-394abb753e2e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1269-17133512690190 CAPSULE in 1 BOTTLE (71335-1269-1) 90 capsule2019-07-110000-00-00NoNoCurrent
71335-1269-27133512690228 CAPSULE in 1 BOTTLE (71335-1269-2) 28 capsule2025-01-300000-00-00NoNoCurrent
71335-1269-37133512690358 CAPSULE in 1 BOTTLE (71335-1269-3) 58 capsule2025-01-300000-00-00NoNoCurrent
71335-1269-47133512690430 CAPSULE in 1 BOTTLE (71335-1269-4) 30 capsule2019-07-150000-00-00NoNoCurrent
71335-1269-57133512690560 CAPSULE in 1 BOTTLE (71335-1269-5) 60 capsule2019-07-090000-00-00NoNoCurrent
71335-1269-671335126906120 CAPSULE in 1 BOTTLE (71335-1269-6) 120 capsule2019-07-310000-00-00NoNoCurrent
71335-1269-771335126907180 CAPSULE in 1 BOTTLE (71335-1269-7) 180 capsule2023-03-290000-00-00NoNoCurrent
71335-1269-87133512690840 CAPSULE in 1 BOTTLE (71335-1269-8) 40 capsule2023-03-290000-00-00NoNoCurrent