FDA.reportPublic FDA data

GABAPENTIN

Product NDC
76420-837
11-digit product format
764200837
Labeler code
76420
Product ID
76420-837_359e91ba-a244-6357-e063-6394a90a9542
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-837-01GABAPENTIN100 in 1 BOTTLETABLET1002
76420-837-05GABAPENTIN500 in 1 BOTTLETABLET5002
76420-837-30GABAPENTIN30 in 1 BOTTLETABLET302
76420-837-60GABAPENTIN60 in 1 BOTTLETABLET602
76420-837-90GABAPENTIN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-837-01EA - Each76420-8374dad13fa-450e-459a-9dad-3ce24ff3863612025-11-13
76420-837-05EA - Each76420-8373848fae3-5bec-4484-869e-c2bcccbce95012025-11-13
76420-837-30EA - Each76420-837a0ddd5eb-572a-4b1a-b27a-d72f6d462a2912025-11-13
76420-837-60EA - Each76420-83727734081-20ba-437b-b922-6c5d56e3e84d12025-11-13
76420-837-90EA - Each76420-8376cac1ef7-4f3f-47db-8f9f-6d1ef017853112025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-837GABAPENTIN TABLET [ASCLEMED USA, INC.]2Current NDC, 5 package rows20250523_1f1203f4-2184-4e13-e063-6394a90a4330.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN1f1203f4-2184-4e13-e063-6394a90a43302
310434gabapentin 800 MG Oral TabletPSN1f1203f4-2184-4e13-e063-6394a90a43302
310433gabapentin 600 MG Oral TabletSCD1f1203f4-2184-4e13-e063-6394a90a43302
310434gabapentin 800 MG Oral TabletSCD1f1203f4-2184-4e13-e063-6394a90a43302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-837-0176420083701100 TABLET in 1 BOTTLE (76420-837-01) 100 tablet2024-08-07NoNoHistorical
76420-837-0576420083705500 TABLET in 1 BOTTLE (76420-837-05) 500 tablet2024-08-07NoNoHistorical
76420-837-307642008373030 TABLET in 1 BOTTLE (76420-837-30) 30 tablet2024-08-07NoNoHistorical
76420-837-607642008376060 TABLET in 1 BOTTLE (76420-837-60) 60 tablet2024-08-07NoNoHistorical
76420-837-907642008379090 TABLET in 1 BOTTLE (76420-837-90) 90 tablet2024-08-07NoNoHistorical