Gabapentin

Product NDC
50090-5961
11-digit product format
500905961
Labeler code
50090
Product ID
50090-5961_63ffaba7-e141-43a3-ad3f-e73e549663aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090858
Marketing category
ANDA
Marketing start
2021-07-15
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5961-0Gabapentin33 in 1 CARTONCAPSULE331
50090-5961-0Gabapentin1 in 1 BLISTER PACKCAPSULE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5961-0EA - Each50090-59610a0b9e43-d2df-459b-9fba-82e82237046c12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5961GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20220416_7eddc9ac-03ba-44c0-b630-ab683bf31e8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN7eddc9ac-03ba-44c0-b630-ab683bf31e8e1
310431gabapentin 300 MG Oral CapsuleSCD7eddc9ac-03ba-44c0-b630-ab683bf31e8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5961-05009059610033 BLISTER PACK in 1 CARTON (50090-5961-0) > 1 CAPSULE in 1 BLISTER PACK33 blister pack2022-04-140000-00-00NoNoCurrent