FDA.reportPublic FDA data

Gemfibrozil

Product NDC
50090-6913
11-digit product format
500906913
Labeler code
50090
Product ID
50090-6913_f0729765-9ea7-4acf-813b-f4de1fa5b717
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079072
Marketing category
ANDA
Marketing start
2010-12-20
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
50090-6913-0Gemfibrozil60 in 1 BOTTLETABLET601
50090-6913-2Gemfibrozil90 in 1 BOTTLETABLET901
50090-6913-3Gemfibrozil30 in 1 BOTTLETABLET301
50090-6913-4Gemfibrozil180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6913-0EA - Each50090-6913f3c8eed6-e722-42bc-9812-b0784595e9db12024-01-04
50090-6913-2EA - Each50090-69134fe0fd8c-6bfe-4d70-9243-bfa73bf8e46712024-01-04
50090-6913-3EA - Each50090-6913f636517d-f7c6-4894-8666-e29e47cada1412024-01-04
50090-6913-4EA - Each50090-6913e05dab58-1e4a-457c-a4c2-45016ec68c7012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6913GEMFIBROZIL TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20231219_4907bbfa-27f4-4569-8957-9704f9c998a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN4907bbfa-27f4-4569-8957-9704f9c998a01
310459gemfibrozil 600 MG Oral TabletSCD4907bbfa-27f4-4569-8957-9704f9c998a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6913-05009069130060 TABLET in 1 BOTTLE (50090-6913-0) 60 tablet2023-12-12NoNoCurrent
50090-6913-25009069130290 TABLET in 1 BOTTLE (50090-6913-2) 90 tablet2023-12-12NoNoCurrent
50090-6913-35009069130330 TABLET in 1 BOTTLE (50090-6913-3) 30 tablet2023-12-12NoNoCurrent
50090-6913-450090691304180 TABLET in 1 BOTTLE (50090-6913-4) 180 tablet2023-12-12NoNoCurrent