FDA.reportPublic FDA data

GABAPENTIN

Product NDC
76282-627
11-digit product format
762820627
Labeler code
76282
Product ID
76282-627_5e0a57d7-9068-43d3-be26-96f646720fde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2018-09-13
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 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
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
76282-627-01GABAPENTIN100 in 1 BOTTLECAPSULE10011
76282-627-05GABAPENTIN500 in 1 BOTTLECAPSULE50011
76282-627-18GABAPENTIN180 in 1 BOTTLECAPSULE18011
76282-627-27GABAPENTIN270 in 1 BOTTLECAPSULE27011
76282-627-30GABAPENTIN30 in 1 BOTTLECAPSULE3011
76282-627-60GABAPENTIN60 in 1 BOTTLECAPSULE6011
76282-627-90GABAPENTIN90 in 1 BOTTLECAPSULE9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-627GABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 7 package rows20241115_41d1ead3-046e-4abf-ae0a-cb126a1f5848.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN41d1ead3-046e-4abf-ae0a-cb126a1f584811
310431gabapentin 300 MG Oral CapsulePSN41d1ead3-046e-4abf-ae0a-cb126a1f584811
310432gabapentin 400 MG Oral CapsulePSN41d1ead3-046e-4abf-ae0a-cb126a1f584811
310430gabapentin 100 MG Oral CapsuleSCD41d1ead3-046e-4abf-ae0a-cb126a1f584811
310431gabapentin 300 MG Oral CapsuleSCD41d1ead3-046e-4abf-ae0a-cb126a1f584811
310432gabapentin 400 MG Oral CapsuleSCD41d1ead3-046e-4abf-ae0a-cb126a1f584811
310431gabapentin 300 MG Oral CapsulePSNa900bafb-8f49-4a01-ba7f-4fb228ec02531
310431gabapentin 300 MG Oral CapsuleSCDa900bafb-8f49-4a01-ba7f-4fb228ec02531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-627-0176282062701100 CAPSULE in 1 BOTTLE (76282-627-01) 100 capsule2018-09-130000-00-00NoNoCurrent
76282-627-0576282062705500 CAPSULE in 1 BOTTLE (76282-627-05) 500 capsule2018-09-130000-00-00NoNoCurrent
76282-627-1876282062718180 CAPSULE in 1 BOTTLE (76282-627-18) 180 capsule2018-09-130000-00-00NoNoCurrent
76282-627-2776282062727270 CAPSULE in 1 BOTTLE (76282-627-27) 270 capsule2018-09-130000-00-00NoNoCurrent
76282-627-307628206273030 CAPSULE in 1 BOTTLE (76282-627-30) 30 capsule2018-09-130000-00-00NoNoCurrent
76282-627-607628206276060 CAPSULE in 1 BOTTLE (76282-627-60) 60 capsule2018-09-130000-00-00NoNoCurrent
76282-627-907628206279090 CAPSULE in 1 BOTTLE (76282-627-90) 90 capsule2018-09-130000-00-00NoNoCurrent