FDA.reportPublic FDA data

GEMFIBROZIL

Product NDC
72865-186
11-digit product format
728650186
Labeler code
72865
Product ID
72865-186_418dc670-97c2-4103-b924-aed5242e9417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214603
Marketing category
ANDA
Marketing start
2021-01-20
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEMFIBROZIL600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ8X02027X3
Rxcui310459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-186-05GEMFIBROZIL500 in 1 BOTTLETABLET5003
72865-186-18GEMFIBROZIL180 in 1 BOTTLETABLET1803
72865-186-60GEMFIBROZIL60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-186-05EA - Each72865-1861d9e1947-f01c-4275-ba0d-7883ed81905c12021-05-05
72865-186-18EA - Each72865-186d269f476-a5cb-4317-8100-ce3443e82ee212021-05-05
72865-186-60EA - Each72865-18668411a88-223e-48cd-b7e9-6f497774183212021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-186GEMFIBROZIL TABLET [XLCARE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20211008_58c1f50b-9f84-42fe-b7dd-6eece286e28b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN58c1f50b-9f84-42fe-b7dd-6eece286e28b3
310459gemfibrozil 600 MG Oral TabletSCD58c1f50b-9f84-42fe-b7dd-6eece286e28b3
310459gemfibrozil 600 MG Oral TabletPSN7379a1c1-d34f-4eb8-acb8-c5cbaea0f0171
310459gemfibrozil 600 MG Oral TabletSCD7379a1c1-d34f-4eb8-acb8-c5cbaea0f0171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-186-0572865018605500 TABLET in 1 BOTTLE (72865-186-05) 500 tablet2021-01-200000-00-00NoNoCurrent
72865-186-1872865018618180 TABLET in 1 BOTTLE (72865-186-18) 180 tablet2021-01-200000-00-00NoNoCurrent
72865-186-607286501866060 TABLET in 1 BOTTLE (72865-186-60) 60 tablet2021-01-200000-00-00NoNoCurrent