FDA.reportPublic FDA data

NDC 53489-285 - Gabapentin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53489-285
Package NDCs from labels
53489-285-07, 53489-285-06, 53489-285-01, 53489-285-03, 53489-285-05, 53489-285-10
Manufacturer
MUTUAL PHARMACEUTICAL COMPANY, INC.
Effective date
2007-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GABAPENTIN CAPSULESMUTUAL PHARMACEUTICAL COMPANY, INC.2007-01-17HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-285-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1001
53489-285-03Gabapentin250 in 1 BOTTLE, PLASTICCAPSULE2501
53489-285-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5001
53489-285-06Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE601
53489-285-07Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE301
53489-285-10Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-285GABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]16 package rows20070202_A36432F9-BDDD-4B22-BE6D-ED6AC2B3846A.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GabapentinACTIVE INGREDIENT6CW7F3G59XGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
GabapentinACTIVE MOIETY6CW7F3G59XGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
Corn starchINACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
D&C Red #33INACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
D&C Yellow #10INACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
D&C Yellow #10 LakeINACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
FD&C Blue #1INACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
FD&C Blue #2INACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
FD&C Red #40INACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
yellow iron oxideINACTIVE INGREDIENTGABAPENTIN (GABAPENTIN) CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC20e48004-d8b6-40fd-929b-b95087b4d85d2022-11-28Warnings, Adverse reactionsExact identifier
rxcui: 310430
GabapentinGABAPENTINProficient Rx LPc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 310432
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC88ac51c4-5fa9-4c35-9c63-f26bcb101d4b2022-10-18Warnings, Adverse reactionsExact identifier
rxcui: 310430
GabapentinGABAPENTINAsclemed USA, Inc.e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310431
GabapentinGABAPENTINProficient Rx LPf651a143-3f88-49c9-b5c4-c9af55aea76a2022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINProficient Rx LP176c5b60-93c2-4574-8b51-c15180912aaa2022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 310432
NeurontinGABAPENTINParke-Davis Div of Pfizer Incee9ad9ed-6d9f-4ee1-9d7f-cfad438df3882022-07-12Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
GabapentinGABAPENTINAsclemed USA, Inc.14b1840d-a2db-4eec-bc25-029e35b042e42022-07-09Warnings, Adverse reactionsExact identifier
rxcui: 310432
rxcui: 310431
GabapentinGABAPENTINProficient Rx LPed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e2022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 310430
GabapentinGABAPENTINProficient Rx LP645824d0-eb3d-442b-806d-36a70796cb8e2022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
GABAPENTINGABAPENTINProficient Rx LPaa3ab216-372a-4a72-bfd1-88a1ffa31ba32022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
GabapentinGABAPENTINProficient Rx LP223a9216-6e07-49b9-8faf-bb4e529a6ae52022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINProficient Rx LP52af51ab-6543-466b-848c-13c588c987892022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
GABAPENTINGABAPENTINProficient Rx LP185f264e-db32-41cd-b90d-519717b978502021-11-01Warnings, Adverse reactionsExact identifier
rxcui: 310432
GabapentinGABAPENTINAmneal Pharmaceuticals of New York LLCb11dbff5-ceee-4a63-a093-f6efebdc2f6f2021-02-03Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
Gaba 300-EZSGABAPENTINPureTek Corporationbb29692e-1546-4d05-a46a-93baf4172c7d2020-11-16Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC3b4395f2-9440-4b67-97cc-5d16f3bdd05e2020-08-14Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINProficient Rx LPded42b88-94dd-462d-bcdf-7fd34d1e49c32020-07-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
GABAPENTINGABAPENTINAsclemed USA, Inc.45039bba-7a96-450c-95be-83a3aa4fcbd22020-06-10Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINProficient Rx LP7d77dae0-df76-4b7b-9690-713e9a60e3cd2019-12-01Warnings, Adverse reactionsExact identifier
rxcui: 310430

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.