Gabapentin

Product NDC
65162-102
11-digit product format
651620102
Labeler code
65162
Product ID
65162-102_0a962d55-bd53-462f-b9a0-0bbb6930c93e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-102-03Gabapentin30 in 1 BOTTLECAPSULE3036
65162-102-10Gabapentin100 in 1 BOTTLECAPSULE10036
65162-102-11Gabapentin1000 in 1 BOTTLECAPSULE100036
65162-102-50Gabapentin500 in 1 BOTTLECAPSULE50036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-102-10EA - Each65162-10254816abd-8ea3-4cfc-98f6-14c5dc76e02112014-07-02
65162-102-11EA - Each65162-102accd4547-daf6-4d82-92db-268073f98c6f12014-07-02
65162-102-50EA - Each65162-102686d102d-e397-4e5a-9213-d39dd92b854512014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [RXCHANGE CO.]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [RXCHANGE CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-102GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS LLC]35Current NDC, Legacy NDC, 4 package rows20250201_507bf6d0-e7a2-413d-9848-cd2445a1411d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN7b404ab9-8a7e-49d4-920f-487875d14e45103
310431gabapentin 300 MG Oral CapsuleSCD7b404ab9-8a7e-49d4-920f-487875d14e45103
310431gabapentin 300 MG Oral CapsulePSNa15d5dcc-63c4-4c06-ab91-5e22cdf234cc102
310431gabapentin 300 MG Oral CapsuleSCDa15d5dcc-63c4-4c06-ab91-5e22cdf234cc102
310430gabapentin 100 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310431gabapentin 300 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310432gabapentin 400 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310430gabapentin 100 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310431gabapentin 300 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310432gabapentin 400 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310431gabapentin 300 MG Oral CapsulePSN506bf880-9564-404c-951a-703797ffdad818
310431gabapentin 300 MG Oral CapsuleSCD506bf880-9564-404c-951a-703797ffdad818
310431gabapentin 300 MG Oral CapsulePSN4a4627ab-3a14-4cf2-8556-01d688cd7f194
310431gabapentin 300 MG Oral CapsuleSCD4a4627ab-3a14-4cf2-8556-01d688cd7f194
310431gabapentin 300 MG Oral CapsulePSN704cbddb-9f6a-450e-8c6e-210f6a1eeb663
310431gabapentin 300 MG Oral CapsuleSCD704cbddb-9f6a-450e-8c6e-210f6a1eeb663
310430gabapentin 100 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsulePSN56f97583-5608-186b-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsulePSN26a628b7-b33f-7f4a-e063-6394a90a07031
310432gabapentin 400 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310430gabapentin 100 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsuleSCD56f97583-5608-186b-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsuleSCD26a628b7-b33f-7f4a-e063-6394a90a07031
310432gabapentin 400 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-102-036516201020330 CAPSULE in 1 BOTTLE (65162-102-03) 30 capsule2009-11-240000-00-00NoNoCurrent
65162-102-1065162010210100 CAPSULE in 1 BOTTLE (65162-102-10) 100 capsule2009-11-240000-00-00NoNoCurrent
65162-102-11651620102111000 CAPSULE in 1 BOTTLE (65162-102-11) 1000 capsule2009-11-240000-00-00NoNoCurrent
65162-102-5065162010250500 CAPSULE in 1 BOTTLE (65162-102-50) 500 capsule2009-11-240000-00-00NoNoCurrent