NDC 85534-0055-01 - 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
85534-0055
Requested NDC
85534-0055-01
Package NDCs from labels
85534-0055-0, 85534-0055-1, 85534-0055-2, 85534-0055-3, 85534-0055-01
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - HAWAII REPACK, INC.HAWAII REPACK, INC.2026-06-26HUMAN PRESCRIPTION DRUG LABEL

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 93 of 123 · 2,444 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINAsclemed USA, Inc.17a62334-209d-4dc1-867a-e5780196a2ca2024-11-05Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a072d5d2-8c75-59cc-e053-2a95a90ac0cc2024-11-05Warnings, Adverse reactionsExact identifier
application number: ANDA090858
rxcui: 310431
unii: 6CW7F3G59X
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINBryant Ranch Prepack7b404ab9-8a7e-49d4-920f-487875d14e452024-11-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepackc33c4d83-cc13-4104-9e24-d4cd40b17b702024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepacke2d9bd8c-3bb9-4945-8e61-7d2703d9008c2024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack5769d849-4f27-4701-97ec-7e3ca07339d72024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINWestminster Pharmaceuticals, LLC2f70c496-b58c-30f5-e054-00144ff8d46c2024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack78088f6a-06a3-422f-b336-4a57a24adc162024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack657349fb-41a9-4814-b4ac-4c5afbdde9472024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepacka15d5dcc-63c4-4c06-ab91-5e22cdf234cc2024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack477691f5-0591-4544-840a-ac590e1f25a12024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINBryant Ranch Prepack506bf880-9564-404c-951a-703797ffdad82024-10-29Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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