FDA.reportPublic FDA data

Gabapentin

Product NDC
72189-392
11-digit product format
721890392
Labeler code
72189
Product ID
72189-392_2c4ce258-41dc-b1b7-e063-6394a90aa5f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204989
Marketing category
ANDA
Marketing start
2022-11-16
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
72189-392-30Gabapentin30 in 1 BOTTLECAPSULE304
72189-392-60Gabapentin60 in 1 BOTTLECAPSULE604
72189-392-72Gabapentin120 in 1 BOTTLECAPSULE1204
72189-392-82Gabapentin180 in 1 BOTTLECAPSULE1804
72189-392-90Gabapentin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-392-30EA - Each72189-39258c0f02d-a372-490a-9df4-a0c65d30e37d12022-12-07
72189-392-60EA - Each72189-392f1141e24-09e3-4a6a-8f94-50856569b7f612022-12-07
72189-392-72EA - Each72189-392d1510302-7234-4b4b-b227-aa98c7cf943412022-12-07
72189-392-82EA - Each72189-392fc1b715d-f47e-4a51-a3de-2560ebbfdb3812023-02-06
72189-392-90EA - Each72189-392f21eb3be-0539-40c1-9d35-b138d5e31f6a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-392GABAPENTIN CAPSULE [DIRECT_RX]4Current NDC, Legacy NDC, 5 package rows20250123_ed9cb5fe-7a2e-e0bc-e053-2a95a90a4470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNed9cb5fe-7a2e-e0bc-e053-2a95a90a44704
310431gabapentin 300 MG Oral CapsuleSCDed9cb5fe-7a2e-e0bc-e053-2a95a90a44704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-392-307218903923030 CAPSULE in 1 BOTTLE (72189-392-30) 30 capsule2022-11-160000-00-00NoNoCurrent
72189-392-607218903926060 CAPSULE in 1 BOTTLE (72189-392-60) 60 capsule2022-11-160000-00-00NoNoCurrent
72189-392-7272189039272120 CAPSULE in 1 BOTTLE (72189-392-72) 120 capsule2022-11-160000-00-00NoNoCurrent
72189-392-8272189039282180 CAPSULE in 1 BOTTLE (72189-392-82) 180 capsule2022-11-160000-00-00NoNoCurrent
72189-392-907218903929090 CAPSULE in 1 BOTTLE (72189-392-90) 90 capsule2022-11-160000-00-00NoNoCurrent