FDA.reportPublic FDA data

Gabapentin

Product NDC
68788-8194
11-digit product format
687888194
Labeler code
68788
Product ID
68788-8194_af8204fd-5b10-49d7-8e0c-4f328fcf9be6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206943
Marketing category
ANDA
Marketing start
2022-05-26
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

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
68788-8194-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1005
68788-8194-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE305
68788-8194-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE605
68788-8194-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1205
68788-8194-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8194-1EA - Each68788-8194d26a24c7-2399-4910-80f9-b35a6307aefa12022-07-06
68788-8194-3EA - Each68788-8194441007e7-6f73-4c6e-b52c-9f7197c9dd6c12022-07-06
68788-8194-6EA - Each68788-819401ae1187-4050-4173-aaf1-05a93338160012022-07-06
68788-8194-8EA - Each68788-819490146401-f88c-4844-bacb-721f295591a012022-07-06
68788-8194-9EA - Each68788-819418761e83-ab93-44aa-aa55-a58a5909881612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8194GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 5 package rows20240504_f396ec70-826d-45c6-a27c-343c2fac878c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNf396ec70-826d-45c6-a27c-343c2fac878c5
310430gabapentin 100 MG Oral CapsuleSCDf396ec70-826d-45c6-a27c-343c2fac878c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8194-168788819401100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8194-1) 100 capsule2022-05-260000-00-00NoNoCurrent
68788-8194-36878881940330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8194-3) 30 capsule2022-05-260000-00-00NoNoCurrent
68788-8194-66878881940660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8194-6) 60 capsule2022-05-260000-00-00NoNoCurrent
68788-8194-868788819408120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8194-8) 120 capsule2022-05-260000-00-00NoNoCurrent
68788-8194-96878881940990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8194-9) 90 capsule2022-05-260000-00-00NoNoCurrent