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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212937-001 PEDMARK SODIUM THIOSULFATE 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212937-001 10596190 2038-01-05 U-3443 Delist requested 2022-10-06 N212937-001 11291728 2039-07-01 Drug product 2022-10-06 N212937-001 11510984 2039-07-01 Drug product 2022-12-14 N212937-001 11617793 2039-07-01 Drug product 2023-04-17 N212937-001 11964018 2039-07-01 U-3898 2024-05-08 N212937-001 11992530 2039-07-01 U-3948 2024-06-20 N212937-001 11998604 2039-07-01 U-3952 2024-06-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212937-001 ODE-384 2029-09-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212937-001 PEDMARK 12.5GM/100ML (125MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-20 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 144 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212937-001 10596190 2038-01-05 U-3443 Delist requested 2022-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212937-001 11291728 2039-07-01 Drug product 2022-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212937-001 11510984 2039-07-01 Drug product 2022-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212937-001 11617793 2039-07-01 Drug product 2023-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212937-001 11964018 2039-07-01 U-3898 2024-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212937-001 11992530 2039-07-01 U-3948 2024-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212937-001 11998604 2039-07-01 U-3952 2024-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212937-001 10596190 2038-01-05 U-3443 Delist requested 2022-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212937-001 11291728 2039-07-01 Drug product 2022-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212937-001 11510984 2039-07-01 Drug product 2022-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212937-001 11617793 2039-07-01 Drug product 2023-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212937-001 11964018 2039-07-01 U-3898 2024-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212937-001 11992530 2039-07-01 U-3948 2024-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212937-001 11998604 2039-07-01 U-3952 2024-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 10596190 2038-01-05 U-3443 Delist requested 2022-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 11291728 2039-07-01 Drug product 2022-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 11510984 2039-07-01 Drug product 2022-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 11617793 2039-07-01 Drug product 2023-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 11964018 2039-07-01 U-3898 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 11992530 2039-07-01 U-3948 2024-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212937-001 11998604 2039-07-01 U-3952 2024-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212937-001 10596190 2038-01-05 U-3443 Delist requested 2022-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212937-001 11291728 2039-07-01 Drug product 2022-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212937-001 11510984 2039-07-01 Drug product 2022-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212937-001 11617793 2039-07-01 Drug product 2023-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212937-001 11964018 2039-07-01 U-3898 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212937-001 11992530 2039-07-01 U-3948 2024-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212937-001 11998604 2039-07-01 U-3952 2024-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 10596190 2038-01-05 U-3443 Delist requested 2022-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 11291728 2039-07-01 Drug product 2022-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 11510984 2039-07-01 Drug product 2022-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 11617793 2039-07-01 Drug product 2023-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 11964018 2039-07-01 U-3898 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 11992530 2039-07-01 U-3948 2024-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212937-001 11998604 2039-07-01 U-3952 2024-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212937-001 10596190 2038-01-05 U-3443 Delist requested 2022-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212937-001 11291728 2039-07-01 Drug product 2022-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212937-001 11510984 2039-07-01 Drug product 2022-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212937-001 11617793 2039-07-01 Drug product 2023-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212937-001 11964018 2039-07-01 U-3898 2024-05-08 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 46 observed states.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HX1032V43M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2618749 Internal RxNorm lookup 2618755 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PEDMARK SODIUM THIOSULFATE Fennec Pharmaceuticals Inc. f98c7076-2a7b-4fd7-ab90-eed5e9137bae 2025-10-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 212937 application number: NDA212937 ndc (product): 73077-010
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