Home NDC 31722-019-31 Diatrizoate Meglumine and Diatrizoate Sodium
Product NDC 31722-019
Requested package NDC 31722-019-31
11-digit product format 317220019
Labeler code 31722
Product ID 31722-019_2e7917f2-e573-cccb-e063-6294a90a203c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diatrizoate Meglumine and Diatrizoate Sodium
Dosage form SOLUTION
Route ORAL; RECTAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA215049
Marketing category ANDA
Marketing start 2023-11-17
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 1 .
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 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215049-001 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 2026-02-19 14:30 UTC 2026-02 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215049-001 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10% SOLUTION / ORAL, RECTAL AA 2023-11-17 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 3X9MR4N98U Internal UNII lookup V5403H8VG7 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 31722-019-12 Diatrizoate Meglumine and Diatrizoate Sodium 120 mL in 1 BOTTLE SOLUTION 120 3 31722-019-30 Diatrizoate Meglumine and Diatrizoate Sodium 30 mL in 1 BOTTLE SOLUTION 30 3 31722-019-31 Diatrizoate Meglumine and Diatrizoate Sodium 24 in 1 BOX SOLUTION 24 3 31722-019-32 Diatrizoate Meglumine and Diatrizoate Sodium 12 in 1 BOX SOLUTION 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-019 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 Current NDC, 4 package rows 20250221_a216a7d5-3c28-482b-956a-93ae146e3763.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 Sample Exclude flag Status 31722-019-31 31722001931 24 BOTTLE in 1 BOX (31722-019-31) / 30 mL in 1 BOTTLE (31722-019-30) 24 bottle 2023-11-17 No No Current