FDA.reportPublic FDA data

NDC 53489-285-01 - 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
Requested NDC
53489-285-01
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 10 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.82c0ed15-9132-657d-e053-2991aa0ae90a2024-06-14Exact identifier
rxcui: 310431
GabapentinGABAPENTINBryant Ranch Prepackffe5321d-3405-46d5-a75f-c51e8f8d87b12024-05-29Warnings, Adverse reactionsExact identifier
rxcui: 310432
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ed219efc-84e3-5bdc-e053-2a95a90a56fc2024-04-11Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINClinical Solutions Wholesale, LLCdbedccfb-0e27-4119-93b9-241c039e045a2024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
GabapentinGABAPENTINBryant Ranch Prepack38210141-bbdc-4186-b71f-54c72f794dca2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 310430
GabapentinGABAPENTINBryant Ranch Prepack75418d32-6504-4cb4-b3a9-afa0eaf19b8d2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 310430
GabapentinGABAPENTINBryant Ranch Prepack1ec656c9-034f-4f14-9e6b-9779d41e16272024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINBryant Ranch Prepack8de89818-805a-4a20-a9b1-48cf443b63152024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 310430
GabapentinGABAPENTINBryant Ranch Prepack9efd0261-9fc9-4dc9-8cf3-9110157ddfc42024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINBryant Ranch Prepack01b810b7-f4c8-4412-bbc5-b9220d8770d82024-04-02Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINMedsource Pharmaceuticals12f0c2ee-9a44-9778-e063-6294a90a3b582024-03-05Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINProficient Rx LP1749d731-bc8c-4374-b2a9-7c809c457f562024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINMedsource Pharmaceuticals1278512b-1493-db65-e063-6394a90ab1612024-02-28Warnings, Adverse reactionsExact identifier
rxcui: 310430
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCf38098ec-dd1a-405a-bbfb-bad62e4e7fa52024-01-04Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
GabapentinGABAPENTINBryant Ranch Prepacke286ed87-5fbc-4ff2-a05e-1f7fa658bbfc2023-12-20Warnings, Adverse reactionsExact identifier
rxcui: 310432
GabapentinGABAPENTINA-S Medication Solutionsecb798a0-377d-4712-bb82-ec9d7116962f2023-12-09Warnings, Adverse reactionsExact identifier
rxcui: 310430
GABAPENTINGABAPENTINAsclemed USA, Inc.5fb79774-c2d4-47ba-9a16-eb367d0fdcff2023-09-30Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINA-S Medication Solutions77d1d90d-e124-4db7-b811-754d535e579c2023-09-10Warnings, Adverse reactionsExact identifier
rxcui: 310431
GabapentinGABAPENTINProficient Rx LP22f2294f-352a-4515-87c8-a6ae46e613222023-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310432
GabapentinGABAPENTINProficient Rx LPf7a943ec-9a13-45ba-9bc5-18162b86b9212023-01-01Warnings, Adverse reactionsExact identifier
rxcui: 310432

Reported adverse events (FAERS/openFDA)#

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