FDA.reportPublic FDA data

Gabapentin

Product NDC
45963-555
11-digit product format
459630555
Labeler code
45963
Product ID
45963-555_63f9a25b-d34f-4b4b-8ccd-e0f6dac569f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA075350
Marketing category
ANDA
Marketing start
2014-04-23
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
45963-555-11Gabapentin100 in 1 BOTTLECAPSULE10023
45963-555-50Gabapentin500 in 1 BOTTLECAPSULE50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-555-11EA - Each45963-5551ef63bf1-289c-40d9-a19b-fe046fd48bb312014-08-01
45963-555-50EA - Each45963-5559a891327-563e-4d62-aa6a-2113d83fc09612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]7
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [DIRECTRX]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [DIRECTRX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [DIRECTRX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABAPENTIN CAPSULE [DIRECTRX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN CAPSULE [DIRECTRX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [DIRECTRX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [DIRECTRX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [DIRECTRX]1
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [DIRECTRX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAPENTIN CAPSULE [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [DIRECTRX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-555GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 2 package rows20250119_5969871e-6c71-4c37-9d63-370718ccc80c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN5969871e-6c71-4c37-9d63-370718ccc80c23
310431gabapentin 300 MG Oral CapsulePSN5969871e-6c71-4c37-9d63-370718ccc80c23
310432gabapentin 400 MG Oral CapsulePSN5969871e-6c71-4c37-9d63-370718ccc80c23
310430gabapentin 100 MG Oral CapsuleSCD5969871e-6c71-4c37-9d63-370718ccc80c23
310431gabapentin 300 MG Oral CapsuleSCD5969871e-6c71-4c37-9d63-370718ccc80c23
310432gabapentin 400 MG Oral CapsuleSCD5969871e-6c71-4c37-9d63-370718ccc80c23
310430gabapentin 100 MG Oral CapsulePSN57a431ef-982d-4d5a-9bf2-e07da192bff76
310430gabapentin 100 MG Oral CapsuleSCD57a431ef-982d-4d5a-9bf2-e07da192bff76
310430gabapentin 100 MG Oral CapsulePSNa23aed54-95ae-462f-a780-04983c69332e5
310430gabapentin 100 MG Oral CapsuleSCDa23aed54-95ae-462f-a780-04983c69332e5
310430gabapentin 100 MG Oral CapsulePSN0cea4ac6-8aeb-4a84-91ee-e170e7dd89af2
310430gabapentin 100 MG Oral CapsulePSNe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310430gabapentin 100 MG Oral CapsulePSN8f9fd7ca-a7c3-12f3-e053-2995a90aee442
310431gabapentin 300 MG Oral CapsulePSNe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310430gabapentin 100 MG Oral CapsuleSCD8f9fd7ca-a7c3-12f3-e053-2995a90aee442
310430gabapentin 100 MG Oral CapsuleSCD0cea4ac6-8aeb-4a84-91ee-e170e7dd89af2
310430gabapentin 100 MG Oral CapsuleSCDe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310431gabapentin 300 MG Oral CapsuleSCDe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310430gabapentin 100 MG Oral CapsulePSN8ae4a0c1-1424-47a9-9a59-7fe38bedc0c71
310430gabapentin 100 MG Oral CapsulePSN37d4d465-19a5-46db-80dc-0b7334b3343a1
310430gabapentin 100 MG Oral CapsuleSCD8ae4a0c1-1424-47a9-9a59-7fe38bedc0c71
310430gabapentin 100 MG Oral CapsuleSCD37d4d465-19a5-46db-80dc-0b7334b3343a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45963-555-00459630555005000 CAPSULE in 1 BOX (45963-555-00)5000 capsule28-MAY-14Current
45963-555-1145963055511100 CAPSULE in 1 BOTTLE (45963-555-11) 100 capsule2014-06-050000-00-00NoNoCurrent
45963-555-5045963055550500 CAPSULE in 1 BOTTLE (45963-555-50) 500 capsule2014-04-232028-06-30NoNoCurrent
45963-555-774596305557738675 CAPSULE in 1 CONTAINER (45963-555-77)38675 capsule18-JAN-24Current