Gabapentin

Product NDC
0904-6823
11-digit product format
009046823
Labeler code
0904
Product ID
0904-6823_07b005ac-d21a-4ed4-a619-38bc75cdd139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6823-61Gabapentin1 in 1 BLISTER PACKTABLET, FILM COATED18
0904-6823-61Gabapentin100 in 1 CARTONTABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6823-61EA - Each0904-68239bd6d6d3-1cec-4d93-bcee-456e37f3d84112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6823GABAPENTIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250116_152adf1d-ec0c-4561-bf80-e4c7da158723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN152adf1d-ec0c-4561-bf80-e4c7da1587238
310434gabapentin 800 MG Oral TabletPSN152adf1d-ec0c-4561-bf80-e4c7da1587238
310433gabapentin 600 MG Oral TabletSCD152adf1d-ec0c-4561-bf80-e4c7da1587238
310434gabapentin 800 MG Oral TabletSCD152adf1d-ec0c-4561-bf80-e4c7da1587238
310433gabapentin 600 MG Oral TabletPSNb2da7d96-73ad-4f44-8784-160a384a09617
310434gabapentin 800 MG Oral TabletPSNb2da7d96-73ad-4f44-8784-160a384a09617
310433gabapentin 600 MG Oral TabletSCDb2da7d96-73ad-4f44-8784-160a384a09617
310434gabapentin 800 MG Oral TabletSCDb2da7d96-73ad-4f44-8784-160a384a09617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6823-6100904682361100 BLISTER PACK in 1 CARTON (0904-6823-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2011-10-060000-00-00NoNoCurrent