FDA.reportPublic FDA data

Gabapentin

Product NDC
72189-419
11-digit product format
721890419
Labeler code
72189
Product ID
72189-419_2c4d0413-c686-1d2a-e063-6394a90a00be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA206943
Marketing category
ANDA
Marketing start
2023-02-06
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
72189-419-30Gabapentin30 in 1 BOTTLECAPSULE306
72189-419-60Gabapentin60 in 1 BOTTLECAPSULE606
72189-419-72Gabapentin120 in 1 BOTTLECAPSULE1206
72189-419-90Gabapentin90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-419-30EA - Each72189-41965e61e5c-d9d5-448d-8818-612bc5ec40c712023-07-06
72189-419-60EA - Each72189-419503f1cb0-3ea2-47cf-8d1e-ec3759b2595512023-07-06
72189-419-72EA - Each72189-419d3fcc42f-66af-4f08-8369-d79d1a4e9a8212023-04-07
72189-419-90EA - Each72189-41900920de1-0a9b-477c-913b-fb814ed5172d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-419GABAPENTIN CAPSULE [DIRECT_RX]6Current NDC, 4 package rows20250123_f40a4ee4-ae8e-769c-e053-2a95a90a344e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNf40a4ee4-ae8e-769c-e053-2a95a90a344e6
310430gabapentin 100 MG Oral CapsuleSCDf40a4ee4-ae8e-769c-e053-2a95a90a344e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-419-307218904193030 CAPSULE in 1 BOTTLE (72189-419-30) 30 capsule2023-02-06NoNoHistorical
72189-419-607218904196060 CAPSULE in 1 BOTTLE (72189-419-60) 60 capsule2023-02-06NoNoHistorical
72189-419-7272189041972120 CAPSULE in 1 BOTTLE (72189-419-72) 120 capsule2023-02-06NoNoHistorical
72189-419-907218904199090 CAPSULE in 1 BOTTLE (72189-419-90) 90 capsule2023-02-06NoNoHistorical