FDA.reportPublic FDA data

GABAPENTIN

Product NDC
68788-8790
11-digit product format
687888790
Labeler code
68788
Product ID
68788-8790_b0ca9e97-d218-4ec2-9b59-575cbc5b7d35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2024-12-16
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8790-1GABAPENTIN100 in 1 BOTTLETABLET1002
68788-8790-3GABAPENTIN30 in 1 BOTTLETABLET302
68788-8790-6GABAPENTIN60 in 1 BOTTLETABLET602
68788-8790-8GABAPENTIN120 in 1 BOTTLETABLET1202
68788-8790-9GABAPENTIN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8790-1EA - Each68788-8790d81d593f-fabb-4fe2-9d3c-025a5360d81012025-01-14
68788-8790-3EA - Each68788-879025f8c360-9798-4b54-a3bf-87470a953c3a12025-01-14
68788-8790-6EA - Each68788-87909f4c599c-ee3e-4f6f-9aae-e8442b4cbf6512025-01-14
68788-8790-8EA - Each68788-87902fca755f-b79b-4f3f-9cde-d031b29cfcd312025-01-14
68788-8790-9EA - Each68788-8790b3bf2d83-d1a3-41d1-82df-75fb3bda127e12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8790GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20241218_60b46f6d-efbc-487a-b672-b20df8b44cc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN60b46f6d-efbc-487a-b672-b20df8b44cc42
310434gabapentin 800 MG Oral TabletSCD60b46f6d-efbc-487a-b672-b20df8b44cc42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8790-168788879001100 TABLET in 1 BOTTLE (68788-8790-1) 100 tablet2024-12-16NoNoHistorical
68788-8790-36878887900330 TABLET in 1 BOTTLE (68788-8790-3) 30 tablet2024-12-16NoNoHistorical
68788-8790-66878887900660 TABLET in 1 BOTTLE (68788-8790-6) 60 tablet2024-12-16NoNoHistorical
68788-8790-868788879008120 TABLET in 1 BOTTLE (68788-8790-8) 120 tablet2024-12-16NoNoHistorical
68788-8790-96878887900990 TABLET in 1 BOTTLE (68788-8790-9) 90 tablet2024-12-16NoNoHistorical