FDA.reportPublic FDA data

Gabapentin

Product NDC
68001-412
11-digit product format
680010412
Labeler code
68001
Product ID
68001-412_5033e422-4653-7be9-e063-6294a90a1400
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA077662
Marketing category
ANDA
Marketing start
2019-09-30
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
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
68001-412-00Gabapentin100 in 1 BOTTLETABLET1006
68001-412-03Gabapentin500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-412-00EA - Each68001-412bb4b0819-4a8a-46a9-bfa4-4f748d200d1112019-12-10
68001-412-03EA - Each68001-412cab17ffe-0385-4362-99f9-a19b59db521612019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-412GABAPENTIN TABLET [BLUEPOINT LABORATORIES]4Current NDC, Legacy NDC, 2 package rows20241027_3368bf70-d466-4765-b2b7-7fe967a8c2b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN3368bf70-d466-4765-b2b7-7fe967a8c2b76
310434gabapentin 800 MG Oral TabletPSN3368bf70-d466-4765-b2b7-7fe967a8c2b76
310433gabapentin 600 MG Oral TabletSCD3368bf70-d466-4765-b2b7-7fe967a8c2b76
310434gabapentin 800 MG Oral TabletSCD3368bf70-d466-4765-b2b7-7fe967a8c2b76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-412-0068001041200100 TABLET in 1 BOTTLE (68001-412-00) 100 tablet2019-09-300000-00-00NoNoCurrent
68001-412-0368001041203500 TABLET in 1 BOTTLE (68001-412-03) 500 tablet2019-09-300000-00-00NoNoCurrent