FDA.reportPublic FDA data

GABAPENTIN

Product NDC
50090-6189
11-digit product format
500906189
Labeler code
50090
Product ID
50090-6189_293a0007-ee4b-46b0-a69e-2ff3622ddcf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui310434

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
50090-6189-0GABAPENTIN60 in 1 BOTTLETABLET603
50090-6189-1GABAPENTIN90 in 1 BOTTLETABLET903
50090-6189-2GABAPENTIN30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6189-0EA - Each50090-61893515e237-6627-4bd8-af9f-ec158cc2484512022-12-07
50090-6189-1EA - Each50090-6189abf94c2e-231d-4526-9936-ee9a4225c98b12022-12-07
50090-6189-2EA - Each50090-6189c23e8240-8456-44ef-a253-a404470928b712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6189GABAPENTIN TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 3 package rows20231102_40bb60c0-a2f3-4e7f-b13c-028c906c4852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN40bb60c0-a2f3-4e7f-b13c-028c906c48523
310434gabapentin 800 MG Oral TabletSCD40bb60c0-a2f3-4e7f-b13c-028c906c48523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6189-05009061890060 TABLET in 1 BOTTLE (50090-6189-0) 60 tablet2022-10-270000-00-00NoNoCurrent
50090-6189-15009061890190 TABLET in 1 BOTTLE (50090-6189-1) 90 tablet2022-10-270000-00-00NoNoCurrent
50090-6189-25009061890230 TABLET in 1 BOTTLE (50090-6189-2) 30 tablet2022-10-270000-00-00NoNoCurrent