Gabapentin

Product NDC
72888-104
11-digit product format
728880104
Labeler code
72888
Product ID
72888-104_4b921bb1-ab2e-af6a-e063-6294a90a0694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA216492
Marketing category
ANDA
Marketing start
2023-01-18
Substance
GABAPENTIN
Active strength
250 mg/5mL
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
GABAPENTIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui283523

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
72888-104-25Gabapentin470 mL in 1 BOTTLESOLUTION4704

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-104-25ML - Milliliter72888-10444c49938-8cc3-4342-bf56-c368405afb4c12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-104GABAPENTIN SOLUTION [ADVAGEN PHARMA LTD]2Current NDC, 1 package rows20231225_bfee67dc-d2b1-4a00-92d9-a42be3189c74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSNbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 50 MG/ML Oral SolutionSCDbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 250 MG per 5 ML Oral SolutionSYbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 300 MG per 6 ML Oral SolutionSYbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 500 MG per 10 ML Oral SolutionSYbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 250 MG in 5 mL Oral SolutionPSN1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 50 MG/ML Oral SolutionSCD1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 250 MG per 5 ML Oral SolutionSY1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 300 MG per 6 ML Oral SolutionSY1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 500 MG per 10 ML Oral SolutionSY1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-104-2572888010425470 mL in 1 BOTTLE (72888-104-25) 470 ml2023-06-12NoNoHistorical