FDA.reportPublic FDA data

GABAPENTIN

Product NDC
68788-8476
11-digit product format
687888476
Labeler code
68788
Product ID
68788-8476_267c9cb8-f321-4784-83f9-01e8cf77b3d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2023-07-05
Substance
GABAPENTIN
Active strength
600 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
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
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
68788-8476-1GABAPENTIN100 in 1 BOTTLETABLET1004
68788-8476-3GABAPENTIN30 in 1 BOTTLETABLET304
68788-8476-6GABAPENTIN60 in 1 BOTTLETABLET604
68788-8476-8GABAPENTIN120 in 1 BOTTLETABLET1204
68788-8476-9GABAPENTIN90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8476-1EA - Each68788-8476373c541f-aa19-4f74-bd00-b6c80673538912023-08-08
68788-8476-3EA - Each68788-8476dd952f18-ac72-4742-9e06-293201b8505312023-08-08
68788-8476-6EA - Each68788-8476b5301a02-938a-4c76-b9ea-63d19637c5fa12023-08-08
68788-8476-8EA - Each68788-847612bcc6d9-20c9-45ba-af5d-ace349fe7ac712023-08-08
68788-8476-9EA - Each68788-84769d5e1f78-dbe1-484a-aed2-f3941d659ebc12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8476GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20240531_38119f2e-33b3-4c3c-99b7-9335d8d280d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN38119f2e-33b3-4c3c-99b7-9335d8d280d44
310433gabapentin 600 MG Oral TabletSCD38119f2e-33b3-4c3c-99b7-9335d8d280d44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8476-168788847601100 TABLET in 1 BOTTLE (68788-8476-1) 100 tablet2023-07-05NoNoHistorical
68788-8476-36878884760330 TABLET in 1 BOTTLE (68788-8476-3) 30 tablet2023-07-05NoNoHistorical
68788-8476-66878884760660 TABLET in 1 BOTTLE (68788-8476-6) 60 tablet2023-07-05NoNoHistorical
68788-8476-868788847608120 TABLET in 1 BOTTLE (68788-8476-8) 120 tablet2023-07-05NoNoHistorical
68788-8476-96878884760990 TABLET in 1 BOTTLE (68788-8476-9) 90 tablet2023-07-05NoNoHistorical