GABAPENTIN

Product NDC
23155-868
11-digit product format
231550868
Labeler code
23155
Product ID
23155-868_5cc5ceff-77b9-40d2-bba6-0d4af992e3f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA211314
Marketing category
ANDA
Marketing start
2023-06-25
Marketing end
2027-01-31
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
23155-868-01GABAPENTIN100 in 1 BOTTLECAPSULE1007
23155-868-05GABAPENTIN500 in 1 BOTTLECAPSULE5007
23155-868-10GABAPENTIN1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-868-01EA - Each23155-868a652fce9-d597-4f54-bb44-204418ea6c5d12023-12-05
23155-868-05EA - Each23155-868c5d7c1ca-7da4-45d2-8e53-87803da89a7812023-12-05
23155-868-10EA - Each23155-86873b1b980-183b-4964-b42c-764afe183ef212023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-868GABAPENTIN CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]5Current NDC, 3 package rows20250529_d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNd8daa30f-1cb3-46aa-9b68-d9aa5b0a21057
310431gabapentin 300 MG Oral CapsulePSNd8daa30f-1cb3-46aa-9b68-d9aa5b0a21057
310432gabapentin 400 MG Oral CapsulePSNd8daa30f-1cb3-46aa-9b68-d9aa5b0a21057
310430gabapentin 100 MG Oral CapsuleSCDd8daa30f-1cb3-46aa-9b68-d9aa5b0a21057
310431gabapentin 300 MG Oral CapsuleSCDd8daa30f-1cb3-46aa-9b68-d9aa5b0a21057
310432gabapentin 400 MG Oral CapsuleSCDd8daa30f-1cb3-46aa-9b68-d9aa5b0a21057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-868-0123155086801100 CAPSULE in 1 BOTTLE (23155-868-01) 100 capsule2023-06-252027-01-31NoNoHistorical
23155-868-0523155086805500 CAPSULE in 1 BOTTLE (23155-868-05) 500 capsule2023-06-252027-01-31NoNoHistorical
23155-868-10231550868101000 in 1 BOTTLEHistorical