FDA.reportPublic FDA data

GEMFIBROZIL

Product NDC
50090-5808
11-digit product format
500905808
Labeler code
50090
Product ID
50090-5808_b54f187d-2cb7-4fb7-9fae-2fc9e812667a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5808-0GEMFIBROZIL60 in 1 BOTTLETABLET607
50090-5808-2GEMFIBROZIL90 in 1 BOTTLETABLET907
50090-5808-3GEMFIBROZIL30 in 1 BOTTLETABLET307
50090-5808-4GEMFIBROZIL180 in 1 BOTTLETABLET1807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5808-0EA - Each50090-58089bed4a79-13c0-49b3-8bc9-85883612f47612022-07-06
50090-5808-2EA - Each50090-5808c200f039-c2c5-4179-950f-9dd42225ec4412022-07-06
50090-5808-3EA - Each50090-58082fd3b1b8-e00c-441d-ae77-246c2b00267712022-07-06
50090-5808-4EA - Each50090-5808d7484385-a804-468f-b20b-b95e7b1da66612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5808GEMFIBROZIL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 4 package rows20231110_1967afce-ce55-4b10-bd8c-e4e94130de87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN1967afce-ce55-4b10-bd8c-e4e94130de877
310459gemfibrozil 600 MG Oral TabletSCD1967afce-ce55-4b10-bd8c-e4e94130de877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5808-05009058080060 TABLET in 1 BOTTLE (50090-5808-0) 60 tablet2021-10-150000-00-00NoNoCurrent
50090-5808-25009058080290 TABLET in 1 BOTTLE (50090-5808-2) 90 tablet2021-10-150000-00-00NoNoCurrent
50090-5808-35009058080330 TABLET in 1 BOTTLE (50090-5808-3) 30 tablet2021-10-150000-00-00NoNoCurrent
50090-5808-450090580804180 TABLET in 1 BOTTLE (50090-5808-4) 180 tablet2021-10-150000-00-00NoNoCurrent