FDA.reportPublic FDA data

Gabapentin

Product NDC
17856-1311
11-digit product format
178561311
Labeler code
17856
Product ID
17856-1311_0c5233fb-d333-4fa5-b082-934cb25a6743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA078974
Marketing category
ANDA
Marketing start
2011-02-23
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
E
Listing certified through
2018-12-31
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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1311-12020-01-31C16284748780-19d75b9d0-8e0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN oral solution Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1311-1Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION53
17856-1311-1Gabapentin72 in 1 CASESOLUTION723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1311GABAPENTIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 2 package rows20161201_52964ad6-708c-46b4-8712-e0467a8e2796.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN52964ad6-708c-46b4-8712-e0467a8e27963
283523gabapentin 50 MG/ML Oral SolutionSCD52964ad6-708c-46b4-8712-e0467a8e27963
283523gabapentin 250 MG per 5 ML Oral SolutionSY52964ad6-708c-46b4-8712-e0467a8e27963
283523gabapentin 300 MG per 6 ML Oral SolutionSY52964ad6-708c-46b4-8712-e0467a8e27963
283523gabapentin 500 MG per 10 ML Oral SolutionSY52964ad6-708c-46b4-8712-e0467a8e27963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-1311-1178561311015 mL in 1 CUP, UNIT-DOSE5 mlHistorical