Gabapentin

Product NDC
17856-0135
11-digit product format
178560135
Labeler code
17856
Product ID
17856-0135_29a73355-ea37-4472-880e-e6f965356f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-04-11
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 mg/800mg
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0135-12020-01-31C16284748780-19d75b9d0-ae6d-f424-e053-dadaa90a57ceGabapentin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0135-1Gabapentin1 mg in 1 DOSE PACKTABLET12
17856-0135-1Gabapentin100 in 1 CONTAINERTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0135GABAPENTIN TABLET [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 2 package rows20170511_f47d512a-5aa1-4b53-93b6-5c4733634ae0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNf47d512a-5aa1-4b53-93b6-5c4733634ae02
310434gabapentin 800 MG Oral TabletSCDf47d512a-5aa1-4b53-93b6-5c4733634ae02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0135-1178560135011 mg in 1 DOSE PACK1 mgHistorical