FDA.reportPublic FDA data

Gabapentin

Product NDC
45963-556
11-digit product format
459630556
Labeler code
45963
Product ID
45963-556_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
2014-04-03
Marketing end
2028-05-31
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin

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
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
45963-556-11Gabapentin100 in 1 BOTTLECAPSULE10023
45963-556-50Gabapentin500 in 1 BOTTLECAPSULE50023
45963-556-11Gaba 300-EZS100 in 1 BOTTLECAPSULE100300 mg4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-556-11EA - Each45963-556b2c1fedc-ccd9-434c-ab5c-bcde6b67970d12014-05-02
45963-556-50EA - Each45963-556c9b555d1-cade-41fd-abde-d484590dc88b12014-06-03

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 [WESTWOOD MANUFACTURING]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [WESTWOOD MANUFACTURING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-556GABAPENTIN CAPSULE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 2 package rows20250119_5969871e-6c71-4c37-9d63-370718ccc80c.zip
45963-556GABA 300-EZS (GABAPENTIN) KIT [PURETEK CORPORATION]4Current NDC, Legacy NDC20201117_bb29692e-1546-4d05-a46a-93baf4172c7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNb4c7388a-19d9-4e3a-83c9-4943fb855be424
310431gabapentin 300 MG Oral CapsuleSCDb4c7388a-19d9-4e3a-83c9-4943fb855be424
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
310431gabapentin 300 MG Oral CapsulePSNafc80b8b-da39-6fb9-e053-2a95a90a2d8e7
310431gabapentin 300 MG Oral CapsulePSNe31879cd-2fd8-4057-b43e-bbb9f307b7617
310431gabapentin 300 MG Oral CapsuleSCDafc80b8b-da39-6fb9-e053-2a95a90a2d8e7
310431gabapentin 300 MG Oral CapsuleSCDe31879cd-2fd8-4057-b43e-bbb9f307b7617
310431gabapentin 300 MG Oral CapsulePSNbb29692e-1546-4d05-a46a-93baf4172c7d4
310431gabapentin 300 MG Oral CapsulePSNf651a143-3f88-49c9-b5c4-c9af55aea76a4
310431gabapentin 300 MG Oral CapsuleSCDbb29692e-1546-4d05-a46a-93baf4172c7d4
310431gabapentin 300 MG Oral CapsuleSCDf651a143-3f88-49c9-b5c4-c9af55aea76a4
310431gabapentin 300 MG Oral CapsulePSN2faccf5e-9a81-3a3a-e054-00144ff8d46c3
310431gabapentin 300 MG Oral CapsulePSNbb0f1cee-1ab7-4306-9023-9553f1bacb503
310431gabapentin 300 MG Oral CapsulePSN1dd86cc8-8e8a-44fb-813e-9f41c922e7b63
310431gabapentin 300 MG Oral CapsuleSCDbb0f1cee-1ab7-4306-9023-9553f1bacb503
310431gabapentin 300 MG Oral CapsuleSCD1dd86cc8-8e8a-44fb-813e-9f41c922e7b63
310431gabapentin 300 MG Oral CapsuleSCD2faccf5e-9a81-3a3a-e054-00144ff8d46c3
310430gabapentin 100 MG Oral CapsulePSNe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310431gabapentin 300 MG Oral CapsulePSN6860c072-fa85-420d-a28c-578275caed222
310431gabapentin 300 MG Oral CapsulePSNe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310430gabapentin 100 MG Oral CapsuleSCDe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310431gabapentin 300 MG Oral CapsuleSCDe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310431gabapentin 300 MG Oral CapsuleSCD6860c072-fa85-420d-a28c-578275caed222
310431gabapentin 300 MG Oral CapsulePSN86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310431gabapentin 300 MG Oral CapsulePSN2b876f1a-49d5-0abe-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsulePSN2f5ac7c6-a926-57df-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsulePSN2f5e3466-1710-1532-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsulePSN2fab077c-d3f3-5f8f-e054-00144ff8d46c1
310432gabapentin 400 MG Oral CapsulePSN86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310431gabapentin 300 MG Oral CapsuleSCD2f5ac7c6-a926-57df-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsuleSCD2f5e3466-1710-1532-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsuleSCD2fab077c-d3f3-5f8f-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsuleSCD86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310431gabapentin 300 MG Oral CapsuleSCD2b876f1a-49d5-0abe-e054-00144ff8d46c1
310432gabapentin 400 MG Oral CapsuleSCD86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45963-556-004596305560010000 CAPSULE in 1 BOX (45963-556-00)10000 capsule28-MAY-14Current
45963-556-1145963055611100 CAPSULE in 1 BOTTLE (45963-556-11) 100 capsule2014-04-032028-02-29NoNoCurrent
45963-556-5045963055650500 CAPSULE in 1 BOTTLE (45963-556-50) 500 capsule2014-05-122028-05-31NoNoCurrent
45963-556-774596305567721050 CAPSULE in 1 CONTAINER (45963-556-77)21050 capsule18-JAN-24Current