FDA.reportPublic FDA data

Gabapentin

Product NDC
45963-557
11-digit product format
459630557
Labeler code
45963
Product ID
45963-557_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
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 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
45963-557-11Gabapentin100 in 1 BOTTLECAPSULE10023
45963-557-50Gabapentin500 in 1 BOTTLECAPSULE50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-557-11EA - Each45963-5576ca654ca-d9e1-4994-b817-2efbe4ce29f212014-06-03
45963-557-50EA - Each45963-5579dc85547-5f8f-47a3-b49f-8884c499c28b12014-05-02

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-557GABAPENTIN 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
310432gabapentin 400 MG Oral CapsulePSN130f4b5b-eefe-4ce6-8555-c872a8082c1726
310432gabapentin 400 MG Oral CapsuleSCD130f4b5b-eefe-4ce6-8555-c872a8082c1726
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
310432gabapentin 400 MG Oral CapsulePSN77754734-4125-42b1-97c8-458bcab2bcf121
310432gabapentin 400 MG Oral CapsuleSCD77754734-4125-42b1-97c8-458bcab2bcf121
310432gabapentin 400 MG Oral CapsulePSNc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a5
310432gabapentin 400 MG Oral CapsulePSNf08849b1-a914-4e94-bbce-ebd72e7859865
310432gabapentin 400 MG Oral CapsuleSCDc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a5
310432gabapentin 400 MG Oral CapsuleSCDf08849b1-a914-4e94-bbce-ebd72e7859865
310432gabapentin 400 MG Oral CapsulePSN74f888ce-5f84-cad0-e053-2991aa0a2d792
310432gabapentin 400 MG Oral CapsuleSCD74f888ce-5f84-cad0-e053-2991aa0a2d792
310431gabapentin 300 MG Oral CapsulePSN86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310432gabapentin 400 MG Oral CapsulePSN86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310431gabapentin 300 MG Oral CapsuleSCD86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491
310432gabapentin 400 MG Oral CapsuleSCD86b30e64-fe56-42b3-a0f8-d9ef5d4b8c491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45963-557-004596305570010000 CAPSULE in 1 BOX (45963-557-00)10000 capsule28-MAY-14Current
45963-557-1145963055711100 CAPSULE in 1 BOTTLE (45963-557-11) 100 capsule2014-05-120000-00-00NoNoCurrent
45963-557-5045963055750500 CAPSULE in 1 BOTTLE (45963-557-50) 500 capsule2014-04-030000-00-00NoNoCurrent
45963-557-774596305577715930 CAPSULE in 1 CONTAINER (45963-557-77)15930 capsule18-JAN-24Current