FDA.reportPublic FDA data

Gabapentin

Product NDC
42806-509
11-digit product format
428060509
Labeler code
42806
Product ID
42806-509_20f2898a-4fc1-450c-a7e8-36e3d8219ee0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA207099
Marketing category
ANDA
Marketing start
2017-03-24
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
42806-509-01Gabapentin100 in 1 BOTTLECAPSULE10010
42806-509-10Gabapentin1000 in 1 BOTTLECAPSULE100010
42806-509-30Gabapentin30 in 1 BOTTLECAPSULE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-509-01EA - Each42806-509193546cd-4fbe-491d-bfb0-6d95062daed112017-06-15
42806-509-10EA - Each42806-509274d013e-7c5c-4313-8157-68ae99d4356612017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-509GABAPENTIN CAPSULE [EPIC PHARMA, LLC]10Current NDC, Legacy NDC, 3 package rows20190108_030e656a-e384-49ac-830f-32140c18112d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN030e656a-e384-49ac-830f-32140c18112d10
310431gabapentin 300 MG Oral CapsulePSN030e656a-e384-49ac-830f-32140c18112d10
310432gabapentin 400 MG Oral CapsulePSN030e656a-e384-49ac-830f-32140c18112d10
310430gabapentin 100 MG Oral CapsuleSCD030e656a-e384-49ac-830f-32140c18112d10
310431gabapentin 300 MG Oral CapsuleSCD030e656a-e384-49ac-830f-32140c18112d10
310432gabapentin 400 MG Oral CapsuleSCD030e656a-e384-49ac-830f-32140c18112d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-509-0142806050901100 CAPSULE in 1 BOTTLE (42806-509-01) 100 capsule2017-03-240000-00-00NoNoCurrent
42806-509-10428060509101000 CAPSULE in 1 BOTTLE (42806-509-10) 1000 capsule2017-03-240000-00-00NoNoCurrent
42806-509-304280605093030 CAPSULE in 1 BOTTLE (42806-509-30) 30 capsule2017-03-240000-00-00NoNoCurrent