Home NDC 73077-010 PEDMARK
Product NDC 73077-010
11-digit product format 730770010
Labeler code 73077
Product ID 73077-010_889accaa-7f62-4da4-84ea-80ecfb144209
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM THIOSULFATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fennec Pharmaceuticals Inc.
Application NDA212937
Marketing category NDA
Marketing start 2022-10-03
Substance SODIUM THIOSULFATE
Active strength 12.5 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PEDMARK
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM THIOSULFATE 12.5 g/100mL
Harmonized Identifiers# Field, Values table Field Values Unii HX1032V43M Rxcui 2618749, 2618755
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73077-010-01 PEDMARK 100 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 100 7 73077-010-01 PEDMARK 1 in 1 BOX, UNIT-DOSE INJECTION, SOLUTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73077-010 PEDMARK (SODIUM THIOSULFATE) INJECTION, SOLUTION [FENNEC PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241027_f98c7076-2a7b-4fd7-ab90-eed5e9137bae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73077-010-01 73077001001 1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSE 2022-10-03 0000-00-00 No No Current