Gabapentin

Product NDC
42806-657
11-digit product format
428060657
Labeler code
42806
Product ID
42806-657_c48c3c6d-4407-4312-8e81-46db64698cb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA216252
Marketing category
ANDA
Marketing start
2024-02-26
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
Rxcui1806380, 1806382

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
42806-657-09Gabapentin90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-657-09EA - Each42806-657c69b7cf2-9106-4fa5-a8fe-c90a2869b2b112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-657GABAPENTIN TABLET [EPIC PHARMA, LLC]1Current NDC, 1 package rows20240228_d592d828-8df1-480d-b179-bb9260a9c824.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806380gabapentin 300 MG Once-Daily Oral TabletPSNd592d828-8df1-480d-b179-bb9260a9c8247
1806382gabapentin 600 MG Once-Daily Oral TabletPSNd592d828-8df1-480d-b179-bb9260a9c8247
1806380Once-Daily gabapentin 300 MG Oral TabletSCDd592d828-8df1-480d-b179-bb9260a9c8247
1806382Once-Daily gabapentin 600 MG Oral TabletSCDd592d828-8df1-480d-b179-bb9260a9c8247
1806380gabapentin 300 MG Once-Daily Oral TabletSYd592d828-8df1-480d-b179-bb9260a9c8247
1806382gabapentin 600 MG Once-Daily Oral TabletSYd592d828-8df1-480d-b179-bb9260a9c8247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42806-657-094280606570990 TABLET in 1 BOTTLE (42806-657-09) 90 tablet2024-02-26NoNoCurrent