FDA.reportPublic FDA data

NDC 68788-8816-09 - 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
68788-8816
Requested NDC
68788-8816-09
Package NDCs from labels
68788-8816-3, 68788-8816-6, 68788-8816-9, 68788-8816-1, 68788-8816-8, 68788-8816-09
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-01-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2025-01-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8816-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1001
68788-8816-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE301
68788-8816-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE601
68788-8816-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1201
68788-8816-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8816GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250123_db57e37f-0a78-4c14-8768-a28bbf9fa0da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8816-1EA - Each68788-8816ab647774-6f27-4c90-ad95-91ac1cc13a5312025-03-04
68788-8816-3EA - Each68788-881660f1efd5-1e35-4f04-b321-fc824624e40e12025-03-04
68788-8816-6EA - Each68788-8816a0214b71-7709-44e7-9cf8-23400736224b12025-03-04
68788-8816-8EA - Each68788-8816e1d18647-d8d4-4aea-acd7-54242f350aa512025-03-04
68788-8816-9EA - Each68788-8816ffeaf050-0737-4ad0-9b35-1e01b6be5d4612025-03-04

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 1 of 122 · 2,435 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINREMEDYREPACK INC.4a975ebe-ae0a-446a-8a3d-2ca325e28f932026-09-11Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.167d8b87-506c-4293-9579-563feaa715832026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINClinical Solutions Wholesale, LLCb7f9a106-52c6-49e4-acf5-8fb07761ba4f2026-09-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.d35cd5ac-5ed6-2405-e053-2995a90a69462026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA204989
rxcui: 310430
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPHOENIX RX LLC5a85ea98-4211-54eb-e063-6294a90aff332026-09-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.3dac0d5f-6e65-4c58-9d2a-4f6910b2d4ef2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.78445dbf-c7cd-419f-a7be-72821e4966282026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.4615aaa7-73d4-4473-8f26-e7a982f8a1662026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINBryant Ranch Prepack1af098ad-28b5-463f-8efa-24d70a77d64c2026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA204989
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack9a2658d5-9b0e-4921-b4c5-4c89f1630d692026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA204989
rxcui: 310430
unii: 6CW7F3G59X
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINBryant Ranch Prepack43cbff48-8219-41ba-b67d-3ae4544b78bb2026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA204989
rxcui: 310432
unii: 6CW7F3G59X
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
GABAPENTINGABAPENTINBryant Ranch Prepack4c22c3e6-2471-4b89-945b-f846c4d7884e2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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