FDA.reportPublic FDA data

GABAPENTIN

Product NDC
76282-321
11-digit product format
762820321
Labeler code
76282
Product ID
76282-321_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
2010-04-26
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
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
76282-321-01GABAPENTIN100 in 1 BOTTLECAPSULE10011
76282-321-05GABAPENTIN500 in 1 BOTTLECAPSULE50011
76282-321-18GABAPENTIN180 in 1 BOTTLECAPSULE18011
76282-321-27GABAPENTIN270 in 1 BOTTLECAPSULE27011
76282-321-90GABAPENTIN90 in 1 BOTTLECAPSULE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-321-01EA - Each76282-3215de4a472-ca83-4f75-8610-f3a53ae6fcfe12013-04-01
76282-321-05EA - Each76282-321d635cb05-21c5-4fde-b5c6-60d126a0264012013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-321GABAPENTIN CAPSULE [EXELAN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 5 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-321-0176282032101100 CAPSULE in 1 BOTTLE (76282-321-01) 100 capsule2010-04-260000-00-00NoNoCurrent
76282-321-0576282032105500 CAPSULE in 1 BOTTLE (76282-321-05) 500 capsule2010-04-260000-00-00NoNoCurrent
76282-321-1876282032118180 CAPSULE in 1 BOTTLE (76282-321-18) 180 capsule2013-03-200000-00-00NoNoCurrent
76282-321-2776282032127270 CAPSULE in 1 BOTTLE (76282-321-27) 270 capsule2013-03-200000-00-00NoNoCurrent
76282-321-907628203219090 CAPSULE in 1 BOTTLE (76282-321-90) 90 capsule2013-03-200000-00-00NoNoCurrent