FDA.reportPublic FDA data

Gabapentin

Product NDC
51224-021
11-digit product format
512240021
Labeler code
51224
Product ID
51224-021_001831ce-47e9-4d0e-9aa5-d566575c2267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA207057
Marketing category
ANDA
Marketing start
2019-05-01
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
51224-021-50Gabapentin100 in 1 BOTTLETABLET, COATED1006
51224-021-60Gabapentin500 in 1 BOTTLETABLET, COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-021-50EA - Each51224-0217d0739e7-6c1a-4cc7-b18b-3f325f65cd3312019-08-06
51224-021-60EA - Each51224-0219ddee949-75ad-4424-8422-3bdc166f6dd512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-021GABAPENTIN TABLET, COATED [TAGI PHARMA, INC.]4Current NDC, Legacy NDC, 2 package rows20210903_725878fa-1e2f-4fee-a9e1-a6e102c79625.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN725878fa-1e2f-4fee-a9e1-a6e102c796256
310434gabapentin 800 MG Oral TabletPSN725878fa-1e2f-4fee-a9e1-a6e102c796256
310433gabapentin 600 MG Oral TabletSCD725878fa-1e2f-4fee-a9e1-a6e102c796256
310434gabapentin 800 MG Oral TabletSCD725878fa-1e2f-4fee-a9e1-a6e102c796256
310433gabapentin 600 MG Oral TabletPSNd8604417-9d43-4d27-a7ce-d4120ff201f42
310433gabapentin 600 MG Oral TabletSCDd8604417-9d43-4d27-a7ce-d4120ff201f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51224-021-5051224002150100 TABLET, COATED in 1 BOTTLE (51224-021-50) 2019-05-010000-00-00NoNoCurrent
51224-021-6051224002160500 TABLET, COATED in 1 BOTTLE (51224-021-60) 2019-05-010000-00-00NoNoCurrent