FDA.reportPublic FDA data

Gabapentin

Product NDC
68788-8563
11-digit product format
687888563
Labeler code
68788
Product ID
68788-8563_561b2673-98f8-484f-88a7-0bc7e46314eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2024-01-10
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
68788-8563-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1003
68788-8563-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE303
68788-8563-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE603
68788-8563-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1203
68788-8563-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8563-1EA - Each68788-85632d1f267e-3ef0-40a5-909c-b3d4c50e286212024-05-16
68788-8563-3EA - Each68788-8563b1437b10-b861-44f9-978a-5bc2b13193f312024-05-16
68788-8563-6EA - Each68788-8563202d078f-b330-4a18-a7dd-a3b5820525eb12024-05-16
68788-8563-8EA - Each68788-856390fccd51-866b-40bb-bb13-63eabd8c807212024-05-16
68788-8563-9EA - Each68788-856347068409-e4a7-4d55-bb57-f3418778c8ca12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8563GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240206_2625c0ef-5295-41de-9e81-88001a6cbecc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN2625c0ef-5295-41de-9e81-88001a6cbecc3
310430gabapentin 100 MG Oral CapsuleSCD2625c0ef-5295-41de-9e81-88001a6cbecc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8563-168788856301100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-1) 100 capsule2024-01-10NoNoHistorical
68788-8563-36878885630330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-3) 30 capsule2024-01-10NoNoHistorical
68788-8563-66878885630660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-6) 60 capsule2024-01-10NoNoHistorical
68788-8563-868788856308120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-8) 120 capsule2024-01-10NoNoHistorical
68788-8563-96878885630990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-9) 90 capsule2024-01-10NoNoHistorical