NDC 85534-0010-03 - 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
85534-0010
Requested NDC
85534-0010-03
Package NDCs from labels
85534-0010-0, 85534-0010-1, 85534-0010-2, 85534-0010-3, 85534-0010-03
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-07-02
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.2026-07-02HUMAN 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 141 of 150 · 2,990 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINProficient Rx LPaa3ab216-372a-4a72-bfd1-88a1ffa31ba32022-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LPb67b7865-df64-429a-9550-5333b9c713ea2022-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA205101
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP223a9216-6e07-49b9-8faf-bb4e529a6ae52022-04-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP2fb2233f-9152-4630-ab39-51a0cda7e5ca2022-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA205101
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP52af51ab-6543-466b-848c-13c588c987892022-04-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP2b76955c-52a4-4026-b286-3da1112fe9892022-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA205101
rxcui: 310434
unii: 6CW7F3G59X
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
gabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC7790d906-af26-4e60-bc6f-e906ec03cc242022-03-21Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da717cf0-54af-c4e2-e053-2995a90ac97c2022-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC7f579665-afb7-4227-98c1-2eafee6505042022-02-28Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
Lyme Disease Support 2ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.OHM PHARMA INC.13b4b78b-f9f7-4cf6-8f43-61679160086b2021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
Lyme Disease Support 1ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.OHM PHARMA INC.035e75d6-aeef-4dfd-b076-9d3d8e4a50862021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
OHM Skin Healing CreamCALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.OHM PHARMA INC.c12e6706-37f0-4900-856c-fc7e7ac3b7242021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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