FDA.reportPublic FDA data

Gabapentin

Product NDC
70166-751
11-digit product format
701660751
Labeler code
70166
Product ID
70166-751_bc2e92e0-9ca3-1403-e053-2a95a90a8d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Lohxa
Application
ANDA076403
Marketing category
ANDA
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
250 mg/5mL
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70166-751-022023-01-30C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-032023-01-30C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-042023-01-30C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-052023-01-30C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-062023-01-30C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-022021-02-25C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-032021-02-25C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-042021-02-25C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-052021-02-25C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-062021-02-25C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-022021-01-29C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-032021-01-29C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-042021-01-29C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-052021-01-29C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-062021-01-29C16284748780-1ba0f9c33-5405-a910-e053-dadaa90a0b85These 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
70166-751-02Gabapentin30 in 1 BOXSOLUTION302
70166-751-02Gabapentin2 mL in 1 SYRINGESOLUTION22
70166-751-03Gabapentin30 in 1 BOXSOLUTION302
70166-751-03Gabapentin3 mL in 1 SYRINGESOLUTION32
70166-751-04Gabapentin4 mL in 1 SYRINGESOLUTION42
70166-751-04Gabapentin30 in 1 BOXSOLUTION302
70166-751-05Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION52
70166-751-05Gabapentin100 in 1 BOXSOLUTION1002
70166-751-06Gabapentin100 in 1 BOXSOLUTION1002
70166-751-06Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-751GABAPENTIN SOLUTION [LOHXA]2Legacy NDC, 10 package rows20210226_2b4d316c-1234-41d7-831d-645b3dd6e448.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 50 MG/ML Oral SolutionSCD2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 250 MG per 5 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 300 MG per 6 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 500 MG per 10 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70166-751-027016607510230 in 1 BOXHistorical
70166-751-037016607510330 in 1 BOXHistorical
70166-751-04701660751044 mL in 1 SYRINGE4 mlHistorical
70166-751-05701660751055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
70166-751-0670166075106100 in 1 BOXHistorical