Gabapentin

Product NDC
55154-8193
11-digit product format
551548193
Labeler code
55154
Product ID
55154-8193_106f02cb-f056-4f14-a23b-8fe667d75f82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078926
Marketing category
ANDA
Marketing start
2019-11-27
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
Rxcui310433, 310434

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
55154-8193-0Gabapentin1 in 1 BLISTER PACKTABLET, FILM COATED18
55154-8193-0Gabapentin10 in 1 BAGTABLET, FILM COATED108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8193GABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]6Current NDC, Legacy NDC, 2 package rows20250309_eeb19a5a-b31d-4df8-9546-0b2b5eb5db07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNeeb19a5a-b31d-4df8-9546-0b2b5eb5db078
310434gabapentin 800 MG Oral TabletPSNeeb19a5a-b31d-4df8-9546-0b2b5eb5db078
310433gabapentin 600 MG Oral TabletSCDeeb19a5a-b31d-4df8-9546-0b2b5eb5db078
310434gabapentin 800 MG Oral TabletSCDeeb19a5a-b31d-4df8-9546-0b2b5eb5db078

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8193-05515481930010 BLISTER PACK in 1 BAG (55154-8193-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2019-11-270000-00-00NoNoCurrent