FDA.reportPublic FDA data

GABAPENTIN

Product NDC
68788-8468
11-digit product format
687888468
Labeler code
68788
Product ID
68788-8468_9cfe07ca-b4b9-4352-bb92-611a46b3ec8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2023-06-26
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8468-1GABAPENTIN100 in 1 BOTTLETABLET1004
68788-8468-3GABAPENTIN30 in 1 BOTTLETABLET304
68788-8468-6GABAPENTIN60 in 1 BOTTLETABLET604
68788-8468-8GABAPENTIN120 in 1 BOTTLETABLET1204
68788-8468-9GABAPENTIN90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8468-1EA - Each68788-8468802a95e4-64e8-402d-8200-810f24cb44a412023-08-08
68788-8468-3EA - Each68788-84689e11995a-4c26-4fc7-a3eb-44255ed71ddc12023-08-08
68788-8468-6EA - Each68788-84682537a4ec-1de6-41bf-a425-0f5b93e4c7ea12023-08-08
68788-8468-8EA - Each68788-84686097f7ef-1944-4c3c-8681-8ca5e8aa655412023-08-08
68788-8468-9EA - Each68788-846897d5c63a-878f-4db3-baeb-bfd2cf475f3f12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8468GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20240601_180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee4
310434gabapentin 800 MG Oral TabletSCD180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8468-168788846801100 TABLET in 1 BOTTLE (68788-8468-1) 100 tablet2023-06-26NoNoHistorical
68788-8468-36878884680330 TABLET in 1 BOTTLE (68788-8468-3) 30 tablet2023-06-26NoNoHistorical
68788-8468-66878884680660 TABLET in 1 BOTTLE (68788-8468-6) 60 tablet2023-06-26NoNoHistorical
68788-8468-868788846808120 TABLET in 1 BOTTLE (68788-8468-8) 120 tablet2023-06-26NoNoHistorical
68788-8468-96878884680990 TABLET in 1 BOTTLE (68788-8468-9) 90 tablet2023-06-26NoNoHistorical