Gabapentin

Product NDC
82619-142
11-digit product format
826190142
Labeler code
82619
Product ID
82619-142_26aae270-f035-5159-e063-6394a90a5376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2024-09-01
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 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
82619-142-01Gabapentin100 in 1 BOTTLECAPSULE1001
82619-142-02Gabapentin500 in 1 BOTTLECAPSULE5001
82619-142-03Gabapentin1000 in 1 BOTTLECAPSULE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82619-142GABAPENTIN CAPSULE [CREEKWOOD PHARMACEUTICALS LLC]1Current NDC, 3 package rows20241115_26aac429-a5cd-33cc-e063-6394a90aecc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN26aac429-a5cd-33cc-e063-6394a90aecc01
310431gabapentin 300 MG Oral CapsulePSN26aac429-a5cd-33cc-e063-6394a90aecc01
310432gabapentin 400 MG Oral CapsulePSN26aac429-a5cd-33cc-e063-6394a90aecc01
310430gabapentin 100 MG Oral CapsuleSCD26aac429-a5cd-33cc-e063-6394a90aecc01
310431gabapentin 300 MG Oral CapsuleSCD26aac429-a5cd-33cc-e063-6394a90aecc01
310432gabapentin 400 MG Oral CapsuleSCD26aac429-a5cd-33cc-e063-6394a90aecc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-142-0182619014201100 CAPSULE in 1 BOTTLE (82619-142-01) 100 capsule2024-09-01NoNoCurrent
82619-142-0282619014202500 CAPSULE in 1 BOTTLE (82619-142-02) 500 capsule2024-09-01NoNoCurrent
82619-142-03826190142031000 CAPSULE in 1 BOTTLE (82619-142-03) 1000 capsule2024-09-01NoNoCurrent