FDA.reportPublic FDA data

NDC 85534-0054-2 - 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
85534-0054
Requested NDC
85534-0054-2
Package NDCs from labels
85534-0054-0, 85534-0054-1, 85534-0054-2, 85534-0054-3
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 5 of 121 · 2,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy4ddcdff5-8f1f-bff3-e063-6294a90a11952026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINHAWAII REPACK, INC.dd7adad2-e2f5-4b43-90a4-522bce0be5b32026-07-02Warnings, Adverse reactionsExact identifier
application number: ANDA204989
ndc (package): 85534-0003-0
ndc (package): 85534-0054-3
ndc (package): 85534-0007-1
ndc (package): 85534-0007-2
ndc (package): 85534-0007-3
ndc (package): 85534-0054-1
ndc (package): 85534-0003-2
ndc (package): 85534-0007-0
ndc (package): 85534-0003-1
ndc (package): 85534-0054-2
ndc (package): 85534-0003-3
ndc (package): 85534-0054-0
ndc (product): 85534-0054
ndc (product): 85534-0003
ndc (product): 85534-0007
ndc11 (package): 85534005402
rxcui: 310430
rxcui: 310432
rxcui: 310431
spl id: 559e72cb-a7f3-e1ed-e063-6294a90ad90a
spl set id: dd7adad2-e2f5-4b43-90a4-522bce0be5b3
unii: 6CW7F3G59X
GabapentinGABAPENTINHAWAII REPACK, INC.f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c2026-07-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
gabapentinGABAPENTINSun Pharmaceutical Industries, Inc.c9a05f0c-b5f0-422c-9d67-6d0efc921a742026-07-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINStrides Pharma Science Limited43b67ae3-ac6f-48f5-8788-9ead083768642026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP9d401e54-d4f5-43ba-b898-dd08fc3c7bfa2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
GraliseGABAPENTINAlmatica Pharma LLC466273b1-c9fc-3930-c94b-aa11394d51402026-06-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINHAWAII REPACK, INC.14d61caa-17ce-4fa2-90fb-1470f3864be82026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy2bc65375-77b8-1e50-e063-6294a90acf8f2026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyba4d863d-be38-8cf5-e053-2995a90a69fb2026-06-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyc85ae572-9893-629e-e053-2995a90a23fc2026-06-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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