FDA.reportPublic FDA data

Gabapentin

Product NDC
72189-471
11-digit product format
721890471
Labeler code
72189
Product ID
72189-471_217602a6-c79c-2d9e-e063-6394a90a63ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA214957
Marketing category
ANDA
Marketing start
2023-05-15
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

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
72189-471-30Gabapentin30 in 1 BOTTLETABLET304
72189-471-60Gabapentin60 in 1 BOTTLETABLET604
72189-471-72Gabapentin120 in 1 BOTTLETABLET1204
72189-471-90Gabapentin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-471-30EA - Each72189-471f0fbb3d6-aaa9-415d-bdd1-8e290bfcaeb012023-10-16
72189-471-60EA - Each72189-4719399f2ea-a1b3-42ed-bd07-74888a48854c12024-10-04
72189-471-72EA - Each72189-47179b1b45f-4d8d-4359-9b5a-e32b1c9d08b012023-06-06
72189-471-90EA - Each72189-471f54f1546-3851-4c77-84b7-9affc65b185912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-471GABAPENTIN TABLET [DIRECT_RX]4Current NDC, 4 package rows20240907_fbc05ceb-2e69-3c37-e053-6394a90ac4f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNfbc05ceb-2e69-3c37-e053-6394a90ac4f44
310433gabapentin 600 MG Oral TabletSCDfbc05ceb-2e69-3c37-e053-6394a90ac4f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-471-307218904713030 TABLET in 1 BOTTLE (72189-471-30) 30 tablet2023-05-15NoNoCurrent
72189-471-607218904716060 TABLET in 1 BOTTLE (72189-471-60) 60 tablet2023-05-15NoNoCurrent
72189-471-7272189047172120 TABLET in 1 BOTTLE (72189-471-72) 120 tablet2023-05-15NoNoCurrent
72189-471-907218904719090 TABLET in 1 BOTTLE (72189-471-90) 90 tablet2023-05-15NoNoCurrent