FDA.reportPublic FDA data

gadoterate meglumine

Product NDC
70436-123
11-digit product format
704360123
Labeler code
70436
Product ID
70436-123_32f1536f-eb01-305c-e063-6294a90a1855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadoterate meglumine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA218073
Marketing category
ANDA
Marketing start
2024-06-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
gadoterate meglumine
Listing expiration
2026-12-31

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
70436-123-31gadoterate meglumine5 mL in 1 VIALINJECTION54
70436-123-31gadoterate meglumine10 in 1 CARTONINJECTION104
70436-123-33gadoterate meglumine10 in 1 CARTONINJECTION104
70436-123-33gadoterate meglumine10 mL in 1 VIALINJECTION104
70436-123-34gadoterate meglumine10 in 1 CARTONINJECTION104
70436-123-34gadoterate meglumine15 mL in 1 VIALINJECTION154
70436-123-35gadoterate meglumine10 in 1 CARTONINJECTION104
70436-123-35gadoterate meglumine20 mL in 1 VIALINJECTION204
70436-123-40gadoterate meglumine100 mL in 1 VIALINJECTION1004
70436-123-56gadoterate meglumine6 in 1 CARTONINJECTION64
70436-123-80gadoterate meglumine1 in 1 CARTONINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-123-31ML - Milliliter70436-123cbcedd06-1875-4241-bbcd-aff2a7cee83512025-01-14
70436-123-33ML - Milliliter70436-1237b1c0249-68b6-497e-ba85-4707d5c0971012025-01-14
70436-123-34ML - Milliliter70436-123eb205ae3-29ad-48fd-bbe0-39311163a9f412025-01-14
70436-123-35ML - Milliliter70436-1231692f383-1aeb-4ed9-adb4-b4f25473bb9b12025-01-14
70436-123-40ML - Milliliter70436-1234469877a-d4d0-4786-80f9-4425e641138612025-01-14
70436-123-56ML - Milliliter70436-12342573e69-c325-4259-ba5d-54c4ea214d7312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-123GADOTERATE MEGLUMINE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]4Current NDC, 8 package rows20250422_85404ca7-dbe7-4d06-b30c-4368dcd33b0b.zip
70436-123GADOTERATE MEGLUMINE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]4Current NDC, 3 package rows20250422_b4159c07-b114-4256-b9a9-e6af811704fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-123-317043601233110 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL10 vial2024-06-28NoNoHistorical
70436-123-337043601233310 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL10 vial2024-06-28NoNoHistorical
70436-123-347043601233410 VIAL in 1 CARTON (70436-123-34) / 15 mL in 1 VIAL10 vial2024-06-28NoNoHistorical
70436-123-357043601233510 VIAL in 1 CARTON (70436-123-35) / 20 mL in 1 VIAL10 vial2024-06-28NoNoHistorical
70436-123-4070436012340100 mL in 1 VIAL100 mlHistorical
70436-123-56704360123566 VIAL in 1 CARTON (70436-123-56) / 100 mL in 1 VIAL (70436-123-40) 6 vial2024-08-01NoNoHistorical
70436-123-80704360123801 VIAL in 1 CARTON (70436-123-80) / 100 mL in 1 VIAL (70436-123-40) 1 vial2024-06-28NoNoHistorical