FDA.reportPublic FDA data

Gabapentin

Product NDC
72189-313
11-digit product format
721890313
Labeler code
72189
Product ID
72189-313_2c3ce8c0-ce1d-23ac-e063-6294a90ab7e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Directrx
Application
ANDA205101
Marketing category
ANDA
Marketing start
2022-01-17
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
72189-313-60Gabapentin60 in 1 BOTTLETABLET604
72189-313-72Gabapentin120 in 1 BOTTLETABLET1204
72189-313-90Gabapentin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-313-60EA - Each72189-3131491c76f-c2ec-4081-8488-0aab202ec16612022-04-06
72189-313-72EA - Each72189-31390c150a4-a505-458e-aa97-eaf1cd85646112022-02-07
72189-313-90EA - Each72189-313e0c7a479-27e8-438b-84a2-07d29179368f12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-313GABAPENTIN TABLET [DIRECTRX]4Current NDC, Legacy NDC, 3 package rows20250122_d5c9dd2c-b8ee-1406-e053-2995a90a0287.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNd5c9dd2c-b8ee-1406-e053-2995a90a02874
310433gabapentin 600 MG Oral TabletSCDd5c9dd2c-b8ee-1406-e053-2995a90a02874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-313-607218903136060 TABLET in 1 BOTTLE (72189-313-60) 60 tablet2022-01-170000-00-00NoNoCurrent
72189-313-7272189031372120 TABLET in 1 BOTTLE (72189-313-72) 120 tablet2022-01-170000-00-00NoNoCurrent
72189-313-907218903139090 TABLET in 1 BOTTLE (72189-313-90) 90 tablet2022-01-170000-00-00NoNoCurrent