FDA.reportPublic FDA data

CLARISCAN

Product NDC
0407-2943
11-digit product format
004072943
Labeler code
0407
Product ID
0407-2943_03f42c78-1d36-46fd-b570-042571e5912e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadoterate meglumine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
GE Healthcare
Application
ANDA210016
Marketing category
ANDA
Marketing start
2019-11-01
Substance
GADOTERATE MEGLUMINE
Active strength
376.9 mg/mL
Pharmacologic classes
Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLARISCAN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOTERATE MEGLUMINE376.9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL0ND3981AG

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5b2d15dc-225b-aca9-f9ef-b38666fe1e57Product name420250620
c34d3757-8380-f2a9-d77b-04fccc1c986eProduct name420250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54Product name120140508
51162ac0-9a99-d9a1-b417-523615d04171Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0407-2943-01CLARISCAN10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1016
0407-2943-01CLARISCAN10 in 1 BOXINJECTION, SOLUTION1016
0407-2943-02CLARISCAN10 in 1 BOXINJECTION, SOLUTION1016
0407-2943-02CLARISCAN15 mL in 1 VIAL, GLASSINJECTION, SOLUTION1516
0407-2943-05CLARISCAN10 in 1 BOXINJECTION, SOLUTION1016
0407-2943-05CLARISCAN20 mL in 1 VIAL, GLASSINJECTION, SOLUTION2016
0407-2943-06CLARISCAN10 in 1 BOXINJECTION, SOLUTION1016
0407-2943-06CLARISCAN5 mL in 1 VIAL, GLASSINJECTION, SOLUTION516
0407-2943-12CLARISCAN10 in 1 BOXINJECTION, SOLUTION1016
0407-2943-12CLARISCAN10 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1016
0407-2943-17CLARISCAN15 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1516
0407-2943-17CLARISCAN10 in 1 BOXINJECTION, SOLUTION1016
0407-2943-22CLARISCAN20 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION2016
0407-2943-22CLARISCAN10 in 1 BOXINJECTION, SOLUTION1016
0407-2943-70CLARISCAN10 in 1 BOXINJECTION, SOLUTION1012
0407-2943-70CLARISCAN100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-2943-01ML - Milliliter0407-2943878de2c0-d1cb-4a0f-847d-c9fbf0a0e37012019-12-10
0407-2943-02ML - Milliliter0407-2943020e2ce7-d859-4800-b2ca-1f908ababba112019-12-10
0407-2943-05ML - Milliliter0407-2943dd79efa7-2e54-42c1-83d6-d95ed4e81c1412019-12-10
0407-2943-06ML - Milliliter0407-2943ea89edb7-32d2-4c85-a9ad-44d0c70ba97912021-06-02
0407-2943-12ML - Milliliter0407-294331797804-685a-4d26-908f-e514c8f6a6c112021-06-02
0407-2943-17ML - Milliliter0407-2943f4247924-4ebf-45f1-a03a-9a49953864c412021-06-02
0407-2943-22ML - Milliliter0407-29434b1756ce-75f7-41e9-a84c-9256e0c4647512021-06-02
0407-2943-70ML - Milliliter0407-2943ae1f5fa4-16a2-499b-beae-892a2db196dc12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0407-2943CLARISCAN (GADOTERATE MEGLUMINE) INJECTION, SOLUTION [GE HEALTHCARE]13Current NDC, Legacy NDC, 14 package rows20241116_6f8c9fac-c995-4bf4-950d-ab89deb291b5.zip
0407-2943CLARISCAN (GADOTERATE MEGLUMINE) INJECTION, SOLUTION [GE HEALTHCARE]9Current NDC, Legacy NDC, 2 package rows20241116_c9e273b3-481f-4899-8913-95aaddcc7662.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0407-2943-010040729430110 VIAL, GLASS in 1 BOX (0407-2943-01) / 10 mL in 1 VIAL, GLASS2019-11-010000-00-00NoNoCurrent
0407-2943-020040729430210 VIAL, GLASS in 1 BOX (0407-2943-02) / 15 mL in 1 VIAL, GLASS2019-11-010000-00-00NoNoCurrent
0407-2943-050040729430510 VIAL, GLASS in 1 BOX (0407-2943-05) / 20 mL in 1 VIAL, GLASS2019-11-010000-00-00NoNoCurrent
0407-2943-060040729430610 VIAL, GLASS in 1 BOX (0407-2943-06) / 5 mL in 1 VIAL, GLASS2019-11-010000-00-00NoNoCurrent
0407-2943-120040729431210 SYRINGE, PLASTIC in 1 BOX (0407-2943-12) / 10 mL in 1 SYRINGE, PLASTIC2020-11-160000-00-00NoNoCurrent
0407-2943-170040729431710 SYRINGE, PLASTIC in 1 BOX (0407-2943-17) / 15 mL in 1 SYRINGE, PLASTIC2020-11-160000-00-00NoNoCurrent
0407-2943-220040729432210 SYRINGE, PLASTIC in 1 BOX (0407-2943-22) / 20 mL in 1 SYRINGE, PLASTIC2020-11-160000-00-00NoNoCurrent
0407-2943-700040729437010 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) / 100 mL in 1 BOTTLE, PLASTIC2020-08-040000-00-00NoNoCurrent