FDA.reportPublic FDA data

Gabapentin

Product NDC
76420-259
11-digit product format
764200259
Labeler code
76420
Product ID
76420-259_227219b4-ec12-cb15-e063-6394a90acd32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
Substance
GABAPENTIN
Active strength
100 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
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
76420-259-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1003
76420-259-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5003
76420-259-12Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1203
76420-259-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE303
76420-259-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE603
76420-259-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-259-01EA - Each76420-2597d0d7420-925f-44ad-8ba4-291214fc41dd12022-10-06
76420-259-05EA - Each76420-2592b95e607-a615-4891-8fcc-4034fb395ae712022-10-06
76420-259-30EA - Each76420-259cedb128a-c730-469e-8082-08e9d02c594112022-10-06
76420-259-60EA - Each76420-25950fee7f1-5fa7-4495-98ef-f5bcf6370b9912022-10-06
76420-259-90EA - Each76420-2594418d615-d773-4ed0-aef5-5dbddc638cde12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-259GABAPENTIN CAPSULE [ASCLEMED USA, INC.]3Current NDC, Legacy NDC, 6 package rows20240921_9a829dc3-b2d8-4d19-a579-0597217cec9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310430gabapentin 100 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-259-0176420025901100 CAPSULE in 1 BOTTLE, PLASTIC (76420-259-01) 100 capsule2022-08-160000-00-00NoNoCurrent
76420-259-0576420025905500 CAPSULE in 1 BOTTLE, PLASTIC (76420-259-05) 500 capsule2022-08-160000-00-00NoNoCurrent
76420-259-1276420025912120 CAPSULE in 1 BOTTLE, PLASTIC (76420-259-12) 120 capsule2024-09-17NoNoHistorical
76420-259-307642002593030 CAPSULE in 1 BOTTLE, PLASTIC (76420-259-30) 30 capsule2022-08-160000-00-00NoNoCurrent
76420-259-607642002596060 CAPSULE in 1 BOTTLE, PLASTIC (76420-259-60) 60 capsule2022-08-160000-00-00NoNoCurrent
76420-259-907642002599090 CAPSULE in 1 BOTTLE, PLASTIC (76420-259-90) 90 capsule2022-08-160000-00-00NoNoCurrent