FDA.reportPublic FDA data

GABAPENTIN

Product NDC
68788-8488
11-digit product format
687888488
Labeler code
68788
Product ID
68788-8488_21e2bec2-1ce9-47cd-92dc-837beca452b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2023-07-21
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
68788-8488-1GABAPENTIN100 in 1 BOTTLETABLET1004
68788-8488-3GABAPENTIN30 in 1 BOTTLETABLET304
68788-8488-6GABAPENTIN60 in 1 BOTTLETABLET604
68788-8488-8GABAPENTIN120 in 1 BOTTLETABLET1204
68788-8488-9GABAPENTIN90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8488-1EA - Each68788-84889e0bcd3a-af83-4cf6-a12c-57a3d273200112023-09-05
68788-8488-3EA - Each68788-84888e7fdb8b-e1f7-4ddd-a6c5-3e3e52a5e9ca12023-09-05
68788-8488-6EA - Each68788-84883a5c6d9f-7320-417d-8647-7bcafd4b762e12023-09-05
68788-8488-8EA - Each68788-84880ae76907-4f24-4731-bb0b-4f784ab5b78012023-09-05
68788-8488-9EA - Each68788-84884309208e-787b-4107-a44e-eda7eef03f3712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8488GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20240531_35da078b-0da0-4757-a6c4-a9144c37e8e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN35da078b-0da0-4757-a6c4-a9144c37e8e14
310433gabapentin 600 MG Oral TabletSCD35da078b-0da0-4757-a6c4-a9144c37e8e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8488-168788848801100 TABLET in 1 BOTTLE (68788-8488-1) 100 tablet2023-07-21NoNoHistorical
68788-8488-36878884880330 TABLET in 1 BOTTLE (68788-8488-3) 30 tablet2023-07-21NoNoHistorical
68788-8488-66878884880660 TABLET in 1 BOTTLE (68788-8488-6) 60 tablet2023-07-21NoNoHistorical
68788-8488-868788848808120 TABLET in 1 BOTTLE (68788-8488-8) 120 tablet2023-07-21NoNoHistorical
68788-8488-96878884880990 TABLET in 1 BOTTLE (68788-8488-9) 90 tablet2023-07-21NoNoHistorical