FDA.reportPublic FDA data

GABAPENTIN

Product NDC
76420-836
11-digit product format
764200836
Labeler code
76420
Product ID
76420-836_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
600 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
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
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
76420-836-01GABAPENTIN100 in 1 BOTTLETABLET1002
76420-836-05GABAPENTIN500 in 1 BOTTLETABLET5002
76420-836-12GABAPENTIN120 in 1 BOTTLETABLET1202
76420-836-30GABAPENTIN30 in 1 BOTTLETABLET302
76420-836-60GABAPENTIN60 in 1 BOTTLETABLET602
76420-836-90GABAPENTIN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-836-01EA - Each76420-8361b9ee8fa-30b2-4917-b8e5-e1b12d945da612025-11-13
76420-836-05EA - Each76420-836b6f64b65-c3b9-46c5-9531-4f344d645a0c12025-11-13
76420-836-12EA - Each76420-836a6208efb-f70f-411d-9df4-a6b6117c23c712025-11-13
76420-836-30EA - Each76420-836f3471f0d-8899-4d32-b513-a73efcea8f5612025-11-13
76420-836-60EA - Each76420-83630fecbd2-52ef-49f5-8b8b-abd099b17e4d12025-11-13
76420-836-90EA - Each76420-8362749da9e-188a-48ce-9f3d-63ba5053847712025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-836GABAPENTIN TABLET [ASCLEMED USA, INC.]2Current NDC, 6 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
76420-836-0176420083601100 TABLET in 1 BOTTLE (76420-836-01) 100 tablet2024-08-07NoNoHistorical
76420-836-0576420083605500 TABLET in 1 BOTTLE (76420-836-05) 500 tablet2024-08-07NoNoHistorical
76420-836-1276420083612120 TABLET in 1 BOTTLE (76420-836-12) 120 tablet2025-05-21NoNoHistorical
76420-836-307642008363030 TABLET in 1 BOTTLE (76420-836-30) 30 tablet2024-08-07NoNoHistorical
76420-836-607642008366060 TABLET in 1 BOTTLE (76420-836-60) 60 tablet2024-08-07NoNoHistorical
76420-836-907642008369090 TABLET in 1 BOTTLE (76420-836-90) 90 tablet2024-08-07NoNoHistorical