Gabapentin

Product NDC
17856-0698
11-digit product format
178560698
Labeler code
17856
Product ID
17856-0698_bf0c7a9e-8e30-4910-8cfc-4d9aef465ca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA202024
Marketing category
ANDA
Marketing start
2018-05-31
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
2019-12-31
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
17856-0698-12025-01-30C16284748780-19d75b9d0-d5af-f424-e053-dadaa90a57ceThese 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
17856-0698-22025-01-30C16284748780-19d75b9d0-d5af-f424-e053-dadaa90a57ceThese 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
17856-0698-32025-01-30C16284748780-19d75b9d0-d5af-f424-e053-dadaa90a57ceThese 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
17856-0698-12023-04-12C16284748780-19d75b9d0-d5af-f424-e053-dadaa90a57ceThese 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
17856-0698-22023-04-12C16284748780-19d75b9d0-d5af-f424-e053-dadaa90a57ceThese 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
17856-0698-12020-01-31C16284748780-19d75b9d0-d5af-f424-e053-dadaa90a57ceThese 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
17856-0698-22020-01-31C16284748780-19d75b9d0-d5af-f424-e053-dadaa90a57ceThese 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
17856-0698-1Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION53
17856-0698-2Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION63
17856-0698-3Gabapentin120 in 1 BOX, UNIT-DOSESOLUTION1203
17856-0698-3Gabapentin2 mL in 1 SYRINGESOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0698GABAPENTIN SOLUTION [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 4 package rows20230413_18cc4e21-8989-43c9-943f-4583b2fe92d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN18cc4e21-8989-43c9-943f-4583b2fe92d33
283523gabapentin 50 MG/ML Oral SolutionSCD18cc4e21-8989-43c9-943f-4583b2fe92d33
283523gabapentin 250 MG per 5 ML Oral SolutionSY18cc4e21-8989-43c9-943f-4583b2fe92d33
283523gabapentin 300 MG per 6 ML Oral SolutionSY18cc4e21-8989-43c9-943f-4583b2fe92d33
283523gabapentin 500 MG per 10 ML Oral SolutionSY18cc4e21-8989-43c9-943f-4583b2fe92d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0698-1178560698015 mL in 1 CUP, UNIT-DOSE5 mlHistorical
17856-0698-2178560698026 mL in 1 CUP, UNIT-DOSE6 mlHistorical
17856-0698-317856069803120 in 1 BOX, UNIT-DOSEHistorical