Home NDC 53041-688 Diatrizoate Meglumine and Diatrizoate Sodium
Product NDC 53041-688
11-digit product format 530410688
Labeler code 53041
Product ID 53041-688_9cfdb214-1075-4449-9a01-f04cf5d0edfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diatrizoate Meglumine and Diatrizoate Sodium
Dosage form SOLUTION
Route ORAL; RECTAL
Labeler Guardian Drug Company
Application ANDA214201
Marketing category ANDA
Marketing start 2019-12-18
Substance DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Active strength 660; 100 mg/mL; mg/mL
Pharmacologic classes Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]
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 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214201-001 AA
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 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214201-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2022-06-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diatrizoate Meglumine and Diatrizoate Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIATRIZOATE MEGLUMINE 660 mg/mL DIATRIZOATE SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V5403H8VG7 Internal UNII lookup 3X9MR4N98U Internal UNII 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 53041-688-03 Diatrizoate Meglumine and Diatrizoate Sodium 120 mL in 1 BOTTLE, PLASTIC SOLUTION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-688 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION [GUARDIAN DRUG COMPANY] 3 Current NDC, Legacy NDC, 1 package rows 20220706_e9da4d3d-d0ca-44f7-aaeb-ae49c3839775.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53041-688-03 53041068803 120 mL in 1 BOTTLE, PLASTIC (53041-688-03) 120 ml 2019-12-18 0000-00-00 No No Current