Gemfibrozil

Product NDC
0093-0670
11-digit product format
000930670
Labeler code
0093
Product ID
0093-0670_c1a5dc78-eab0-4d04-8dae-ac59a1f97ff9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074256
Marketing category
ANDA
Marketing start
1993-11-24
Marketing end
2020-03-31
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
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0670-05EA - Each0093-06704bceda1a-6c3a-4462-b680-a3889828366712012-07-24
0093-0670-06EA - Each0093-0670520f7fab-9782-40ec-8b80-ec3a5f60e8fc12012-07-24
0093-0670-19EA - Each0093-067064a08106-fa2a-4e5a-9074-74d5e913c42912012-07-24
0093-0670-93EA - Each0093-0670dd1d1c1a-fb90-4ce2-b527-c1cdb550844b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95GEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN1c8945d1-2292-4c31-8ba4-19bece8cec8d1
310459gemfibrozil 600 MG Oral TabletPSN7e877a90-e00f-45b2-a8e9-a9f70dfa89271
310459gemfibrozil 600 MG Oral TabletPSNfb2df26c-60c6-4aef-986d-2423644897171
310459gemfibrozil 600 MG Oral TabletSCD1c8945d1-2292-4c31-8ba4-19bece8cec8d1
310459gemfibrozil 600 MG Oral TabletSCD7e877a90-e00f-45b2-a8e9-a9f70dfa89271
310459gemfibrozil 600 MG Oral TabletSCDfb2df26c-60c6-4aef-986d-2423644897171