Gabapentin

Product NDC
55154-8195
11-digit product format
551548195
Labeler code
55154
Product ID
55154-8195_26c2b764-1e2b-4509-8fdf-7e19d701b662
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090858
Marketing category
ANDA
Marketing start
2020-11-25
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431

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
55154-8195-0Gabapentin10 in 1 BAGCAPSULE105
55154-8195-0Gabapentin1 in 1 BLISTER PACKCAPSULE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8195GABAPENTIN CAPSULE [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20240805_d4f21e97-5e55-44c9-9b31-5f79ac2eb512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNd4f21e97-5e55-44c9-9b31-5f79ac2eb5126
310431gabapentin 300 MG Oral CapsulePSNd4f21e97-5e55-44c9-9b31-5f79ac2eb5126
310430gabapentin 100 MG Oral CapsuleSCDd4f21e97-5e55-44c9-9b31-5f79ac2eb5126
310431gabapentin 300 MG Oral CapsuleSCDd4f21e97-5e55-44c9-9b31-5f79ac2eb5126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8195-05515481950010 BLISTER PACK in 1 BAG (55154-8195-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack2020-11-250000-00-00NoNoCurrent