FDA.reportPublic FDA data

Gabapentin

Product NDC
17856-0600
11-digit product format
178560600
Labeler code
17856
Product ID
17856-0600_361f9f34-f186-da49-e063-6394a90a3d51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA076403
Marketing category
ANDA
Marketing start
2018-06-29
Substance
GABAPENTIN
Active strength
250 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui283523

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
17856-0600-12024-05-07C16284748780-19d75b9d0-256c-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
17856-0600-22024-05-07C16284748780-19d75b9d0-256c-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
17856-0600-72024-05-07C16284748780-19d75b9d0-256c-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
17856-0600-12024-01-30C16284748780-19d75b9d0-256c-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
17856-0600-22024-01-30C16284748780-19d75b9d0-256c-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
17856-0600-72024-01-30C16284748780-19d75b9d0-256c-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
17856-0600-12020-02-18C16284748780-19d75b9d0-256c-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
17856-0600-22020-02-18C16284748780-19d75b9d0-256c-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
17856-0600-12020-01-31C16284748780-19d75b9d0-256c-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
17856-0600-22020-01-31C16284748780-19d75b9d0-256c-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
17856-0600-1Gabapentin72 in 1 BOXSOLUTION727
17856-0600-2Gabapentin72 in 1 BOXSOLUTION727
17856-0600-3Gabapentin120 in 1 BOX, UNIT-DOSESOLUTION1207
17856-0600-4Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION57
17856-0600-5Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION67
17856-0600-6Gabapentin2 mL in 1 SYRINGESOLUTION27
17856-0600-7Gabapentin5 in 1 SYRINGESOLUTION57
17856-0600-8Gabapentin60 in 1 BOX, UNIT-DOSESOLUTION607
17856-0600-9Gabapentin2 mL in 1 SYRINGESOLUTION27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0600-1ML - Milliliter17856-0600247f9fe7-7bc3-4c3a-af79-da6efd4fc39b12025-06-13
17856-0600-2ML - Milliliter17856-06001da3e4a4-4f69-4ef7-bf22-970e207c979612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0600GABAPENTIN SOLUTION [ATLANTIC BIOLOGICALS CORP.]7Current NDC, Legacy NDC, 9 package rows20250529_5969f1a8-d6d5-4967-add5-4e2492354d7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 50 MG/ML Oral SolutionSCD5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 250 MG per 5 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 300 MG per 6 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 500 MG per 10 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0600-11785606000172 CUP, UNIT-DOSE in 1 BOX (17856-0600-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0600-4) 2024-05-070000-00-00NoNoCurrent
17856-0600-21785606000272 CUP, UNIT-DOSE in 1 BOX (17856-0600-2) / 6 mL in 1 CUP, UNIT-DOSE (17856-0600-5) 2024-05-070000-00-00NoNoCurrent
17856-0600-317856060003120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-3) > 2 mL in 1 SYRINGE120 syringe2021-02-080000-00-00NoNoCurrent
17856-0600-4178560600045 mL in 1 CUP, UNIT-DOSE5 mlHistorical
17856-0600-5178560600056 mL in 1 CUP, UNIT-DOSE6 mlHistorical
17856-0600-6178560600062 mL in 1 SYRINGE2 mlHistorical
17856-0600-7178560600075 BOX, UNIT-DOSE in 1 SYRINGE (17856-0600-7) / 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-3) / 2 mL in 1 SYRINGE (17856-0600-6) 2024-05-070000-00-00NoNoCurrent
17856-0600-81785606000860 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-8) / 2 mL in 1 SYRINGE (17856-0600-9) 60 syringe2025-02-05NoNoHistorical
17856-0600-9178560600092 mL in 1 SYRINGE2 mlHistorical