Gabapentin

Product NDC
63629-8490
11-digit product format
636298490
Labeler code
63629
Product ID
63629-8490_ec71df33-1350-4b90-b82b-87b62842f4dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-02-04
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

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
63629-8490-1Gabapentin100 in 1 BOTTLETABLET100105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8490GABAPENTIN TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241220_d1aa4690-57b5-4a3e-ac12-85f777dbd05e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNd1aa4690-57b5-4a3e-ac12-85f777dbd05e105
310434gabapentin 800 MG Oral TabletSCDd1aa4690-57b5-4a3e-ac12-85f777dbd05e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8490-163629849001100 TABLET in 1 BOTTLE (63629-8490-1) 100 tablet2018-08-200000-00-00NoNoCurrent