FDA.reportPublic FDA data

Gabapentin

Product NDC
60687-507
11-digit product format
606870507
Labeler code
60687
Product ID
60687-507_37dcca50-b1a8-24e7-e063-6394a90a8adf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078926
Marketing category
ANDA
Marketing start
2020-03-24
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-507-01Gabapentin100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1006
60687-507-11Gabapentin1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-507-01EA - Each60687-5076faa79b7-f9e4-4a00-9984-2ca336fae93612020-02-13
60687-507-11EA - Each60687-507b5658512-6d9d-4bd1-b0fd-351977c8f62512020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-507GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20240605_765c7ce0-bbf5-4265-8ff0-1ba092c69865.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNeeb19a5a-b31d-4df8-9546-0b2b5eb5db078
310434gabapentin 800 MG Oral TabletPSNeeb19a5a-b31d-4df8-9546-0b2b5eb5db078
310433gabapentin 600 MG Oral TabletSCDeeb19a5a-b31d-4df8-9546-0b2b5eb5db078
310434gabapentin 800 MG Oral TabletSCDeeb19a5a-b31d-4df8-9546-0b2b5eb5db078
310433gabapentin 600 MG Oral TabletPSN765c7ce0-bbf5-4265-8ff0-1ba092c698656
310434gabapentin 800 MG Oral TabletPSN765c7ce0-bbf5-4265-8ff0-1ba092c698656
310433gabapentin 600 MG Oral TabletSCD765c7ce0-bbf5-4265-8ff0-1ba092c698656
310434gabapentin 800 MG Oral TabletSCD765c7ce0-bbf5-4265-8ff0-1ba092c698656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-507-0160687050701100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-507-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-507-11) 100 blister pack2020-03-240000-00-00NoNoCurrent
60687-507-11606870507111 in 1 BLISTER PACKHistorical