FDA.reportPublic FDA data

NDC 50383-350-05 - 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
50383-350
Requested NDC
50383-350-05
Package NDCs from labels
50383-350-05, 50383-350-07
Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2022-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - Akorn | Akorn Operating Company LLCAkorn | Akorn Operating Company LLC2022-03-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-350-072024-01-30C16284748780-11030e365-6b0c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-350-05Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION521
50383-350-07Gabapentin4 in 1 CASESOLUTION421
50383-350-07Gabapentin10 in 1 TRAYSOLUTION1021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-350GABAPENTIN SOLUTION [AKORN]21Legacy NDC, 3 package rows20220315_c64c09c9-0567-4a4f-b2c6-8f667986c9af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14

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 47 · 935 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINREMEDYREPACK INC.4a975ebe-ae0a-446a-8a3d-2ca325e28f932026-09-11Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.167d8b87-506c-4293-9579-563feaa715832026-09-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINClinical Solutions Wholesale, LLCb7f9a106-52c6-49e4-acf5-8fb07761ba4f2026-09-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.d35cd5ac-5ed6-2405-e053-2995a90a69462026-09-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPHOENIX RX LLC5a85ea98-4211-54eb-e063-6294a90aff332026-09-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2026-09-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.78445dbf-c7cd-419f-a7be-72821e4966282026-08-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.4615aaa7-73d4-4473-8f26-e7a982f8a1662026-08-27Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack1af098ad-28b5-463f-8efa-24d70a77d64c2026-08-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack9a2658d5-9b0e-4921-b4c5-4c89f1630d692026-08-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
GabapentinGABAPENTINBryant Ranch Prepack43cbff48-8219-41ba-b67d-3ae4544b78bb2026-08-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack4c22c3e6-2471-4b89-945b-f846c4d7884e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-08-21Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.7652adc6-1aad-4422-b85c-0c6b11c23b732026-08-21Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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