Gabapentin

Product NDC
72888-131
11-digit product format
728880131
Labeler code
72888
Product ID
72888-131_4b9217ba-8356-aab1-e063-6294a90a2dce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA077661
Marketing category
ANDA
Marketing start
2022-09-22
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 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
72888-131-00Gabapentin1000 in 1 BOTTLETABLET10003
72888-131-01Gabapentin100 in 1 BOTTLETABLET1003
72888-131-05Gabapentin500 in 1 BOTTLETABLET5003
72888-131-30Gabapentin30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-131-01EA - Each72888-131dd0c2c6f-15e6-445e-b8ad-e94d6554306b12023-09-05
72888-131-05EA - Each72888-131f7569ef8-6875-4063-80a7-7bd1d13769bd12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-131GABAPENTIN TABLET [ADVAGEN PHARMA LTD]1Current NDC, Legacy NDC, 4 package rows20221013_401b30fc-e143-4906-aae1-e5b5c190d4a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN401b30fc-e143-4906-aae1-e5b5c190d4a83
310434gabapentin 800 MG Oral TabletPSN401b30fc-e143-4906-aae1-e5b5c190d4a83
310433gabapentin 600 MG Oral TabletSCD401b30fc-e143-4906-aae1-e5b5c190d4a83
310434gabapentin 800 MG Oral TabletSCD401b30fc-e143-4906-aae1-e5b5c190d4a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-131-00728880131001000 TABLET in 1 BOTTLE (72888-131-00) 1000 tablet2022-09-220000-00-00NoNoCurrent
72888-131-0172888013101100 TABLET in 1 BOTTLE (72888-131-01) 100 tablet2022-09-220000-00-00NoNoCurrent
72888-131-0572888013105500 TABLET in 1 BOTTLE (72888-131-05) 500 tablet2022-09-220000-00-00NoNoCurrent
72888-131-307288801313030 TABLET in 1 BOTTLE (72888-131-30) 30 tablet2022-09-220000-00-00NoNoCurrent