FDA.reportPublic FDA data

Cefepime Hydrochloride

Product NDC
0781-3223
11-digit product format
007813223
Labeler code
0781
Product ID
0781-3223_18bf4c29-e238-45aa-b976-d2d600fb0609
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefepime Hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA065441
Marketing category
ANDA
Marketing start
2008-05-01
Marketing end
0000-00-00
Substance
CEFEPIME HYDROCHLORIDE
Active strength
2 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4878f213-798f-d240-b895-da945519fdacProduct name520250221
2c48ebbc-4556-4270-89c4-74bed6fedfeaProduct name120250117
c050dd27-f8ee-4d60-beb5-08930938e02eProduct name120231115
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
61f3932f-d389-4aed-124d-cf14f88e190fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3223-952020-01-31C16284748780-19d75b9d0-211c-f424-e053-dadaa90a57ceCefepime for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3223-91Cefepime Hydrochloride1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION113
0781-3223-95Cefepime Hydrochloride10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3223-91EA - Each0781-3223026db966-edc9-436d-9558-e3a9fc99ac2a12013-02-13
0781-3223-95EA - Each0781-32239669fa35-ce0f-4ce5-be26-c83d3611854b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFEPIME HYDROCHLORIDEACTIVE INGREDIENTI8X1O0607PCEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]13
CEFEPIMEACTIVE MOIETY807PW4VQE3CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]13
ARGININEINACTIVE INGREDIENT94ZLA3W45FCEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3223CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]13Legacy NDC, 2 package rows20150817_1eb8794e-2502-43cc-8a32-dcba78031f15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSN1eb8794e-2502-43cc-8a32-dcba78031f1513
1665088cefepime 2 GM InjectionPSN1eb8794e-2502-43cc-8a32-dcba78031f1513
1665093cefepime 1000 MG InjectionSCD1eb8794e-2502-43cc-8a32-dcba78031f1513
1665088cefepime 2000 MG InjectionSCD1eb8794e-2502-43cc-8a32-dcba78031f1513
1665093cefepime 1 GM (as cefepime HCl) InjectionSY1eb8794e-2502-43cc-8a32-dcba78031f1513
1665088cefepime 2 GM (as cefepime HCl) InjectionSY1eb8794e-2502-43cc-8a32-dcba78031f1513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0781-3223-91007813223911 in 1 VIAL, SINGLE-DOSEHistorical
0781-3223-950078132239510 in 1 CARTONHistorical