FDA.reportPublic FDA data

Gemfibrozil

Product NDC
16714-101
11-digit product format
167140101
Labeler code
16714
Product ID
16714-101_ff9c9bd0-e2a2-4e38-aa8b-16d215d36450
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA079072
Marketing category
ANDA
Marketing start
2010-12-20
Marketing end
2026-12-31
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gemfibrozil

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
16714-101-02Gemfibrozil60 in 1 BOTTLETABLET6025
16714-101-05Gemfibrozil500 in 1 BOTTLETABLET50025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-101-02EA - Each16714-10175e68a39-a906-495c-b663-b1d24bf8134412012-07-24
16714-101-05EA - Each16714-1016d6ed0f6-38a1-4b4e-b2ce-c512a61e2c9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET [NORTHSTAR RXLLC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET [NORTHSTAR RXLLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-101GEMFIBROZIL TABLET [NORTHSTAR RXLLC]24Current NDC, Legacy NDC, 2 package rows20240731_75cac02c-56e3-4dfe-b1e2-4ce166b28833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN75cac02c-56e3-4dfe-b1e2-4ce166b2883325
310459gemfibrozil 600 MG Oral TabletSCD75cac02c-56e3-4dfe-b1e2-4ce166b2883325
310459gemfibrozil 600 MG Oral TabletPSNc3542eba-3c1d-57ba-e053-2995a90a517b24
310459gemfibrozil 600 MG Oral TabletSCDc3542eba-3c1d-57ba-e053-2995a90a517b24
310459gemfibrozil 600 MG Oral TabletPSN325afd72-9176-4a08-8383-58cecb35196d5
310459gemfibrozil 600 MG Oral TabletSCD325afd72-9176-4a08-8383-58cecb35196d5
310459gemfibrozil 600 MG Oral TabletPSN4907bbfa-27f4-4569-8957-9704f9c998a01
310459gemfibrozil 600 MG Oral TabletPSN5738f713-d4b4-437c-b931-fb3b2c22f6d31
310459gemfibrozil 600 MG Oral TabletSCD4907bbfa-27f4-4569-8957-9704f9c998a01
310459gemfibrozil 600 MG Oral TabletSCD5738f713-d4b4-437c-b931-fb3b2c22f6d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-101-021671401010260 TABLET in 1 BOTTLE (16714-101-02) 60 tablet2010-12-202026-11-30NoNoCurrent
16714-101-0516714010105500 TABLET in 1 BOTTLE (16714-101-05) 500 tablet2010-12-202026-12-31NoNoCurrent