Gabapentin

Product NDC
68788-8199
11-digit product format
687888199
Labeler code
68788
Product ID
68788-8199_7797ee73-8a7b-4cb0-aa70-ed3b94aab693
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206943
Marketing category
ANDA
Marketing start
2022-05-23
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
68788-8199-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1005
68788-8199-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE305
68788-8199-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE605
68788-8199-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1205
68788-8199-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8199GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 5 package rows20240504_6ecf5114-2ddc-4025-a36d-1884702dc22a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN6ecf5114-2ddc-4025-a36d-1884702dc22a5
310430gabapentin 100 MG Oral CapsuleSCD6ecf5114-2ddc-4025-a36d-1884702dc22a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8199-168788819901100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-1) 100 capsule2022-05-230000-00-00NoNoCurrent
68788-8199-36878881990330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-3) 30 capsule2022-05-230000-00-00NoNoCurrent
68788-8199-66878881990660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-6) 60 capsule2022-05-230000-00-00NoNoCurrent
68788-8199-868788819908120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-8) 120 capsule2022-05-230000-00-00NoNoCurrent
68788-8199-96878881990990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-9) 90 capsule2022-05-230000-00-00NoNoCurrent