Gemfibrozil

Product NDC
31722-225
11-digit product format
317220225
Labeler code
31722
Product ID
31722-225_183f6e6f-ebb2-410e-9181-3558f0d37a4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals
Application
ANDA077836
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-225-01EA - Each31722-22518d7eee1-4c9b-4d77-b87d-dfcaa39d8d3612012-07-24
31722-225-05EA - Each31722-225d626e242-2a23-4d29-8b9c-457635892b6712012-07-24
31722-225-60EA - Each31722-2257ae62009-9261-47c5-af34-f82ead9b5e9012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-225GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS]3Legacy NDC20150325_c1608dac-9f44-4cf8-83d5-f8ef0c7839b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN0be27c35-d503-49e4-a13a-99d2953eefa42
310459gemfibrozil 600 MG Oral TabletPSN261817da-b8d6-2b32-e054-00144ff8d46c2
310459gemfibrozil 600 MG Oral TabletSCD0be27c35-d503-49e4-a13a-99d2953eefa42
310459gemfibrozil 600 MG Oral TabletSCD261817da-b8d6-2b32-e054-00144ff8d46c2
310459gemfibrozil 600 MG Oral TabletPSNd709812f-e958-4065-a447-c2c00ddd76771
310459gemfibrozil 600 MG Oral TabletPSNe2ec8e47-8f4e-44cc-82ff-1d4511d3fadd1
310459gemfibrozil 600 MG Oral TabletSCDd709812f-e958-4065-a447-c2c00ddd76771
310459gemfibrozil 600 MG Oral TabletSCDe2ec8e47-8f4e-44cc-82ff-1d4511d3fadd1