FDA.reportPublic FDA data

GABAPENTIN

Product NDC
68788-4107
11-digit product format
687884107
Labeler code
68788
Product ID
68788-4107_dd0e12c2-1986-4ca3-a809-d703a7542419
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214956
Marketing category
ANDA
Marketing start
2026-04-22
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
68788-4107-1GABAPENTIN100 in 1 BOTTLECAPSULE1001
68788-4107-3GABAPENTIN30 in 1 BOTTLECAPSULE301
68788-4107-6GABAPENTIN60 in 1 BOTTLECAPSULE601
68788-4107-8GABAPENTIN120 in 1 BOTTLECAPSULE1201
68788-4107-9GABAPENTIN90 in 1 BOTTLECAPSULE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNdd0e12c2-1986-4ca3-a809-d703a75424191
310430gabapentin 100 MG Oral CapsuleSCDdd0e12c2-1986-4ca3-a809-d703a75424191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4107-168788410701100 CAPSULE in 1 BOTTLE (68788-4107-1) 100 capsule2026-04-22NoNoHistorical
68788-4107-36878841070330 CAPSULE in 1 BOTTLE (68788-4107-3) 30 capsule2026-04-22NoNoHistorical
68788-4107-66878841070660 CAPSULE in 1 BOTTLE (68788-4107-6) 60 capsule2026-04-22NoNoHistorical
68788-4107-868788410708120 CAPSULE in 1 BOTTLE (68788-4107-8) 120 capsule2026-04-22NoNoHistorical
68788-4107-96878841070990 CAPSULE in 1 BOTTLE (68788-4107-9) 90 capsule2026-04-22NoNoHistorical