What is NDC 53041-688?

53041-688 is the product NDC for Diatrizoate Meglumine and Diatrizoate Sodium, Diatrizoate meglumine 660 mg/mL; Diatrizoate sodium 100 mg/mL solution, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Diatrizoate meglumine, Diatrizoate sodium.

Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diatrizoate Meglumine and Diatrizoate Sodium?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diatrizoate Meglumine and Diatrizoate Sodium NDC 53041-688

NDC codes

FDA NDC Directory

Product NDC (as listed)53041-688Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53041-0688Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
53041-688-03	53041068803	120 mL in 1 BOTTLE, PLASTIC (53041-688-03)Marketed from Dec 18, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Diatrizoate Meglumine and Diatrizoate Sodium
Generic name (nonproprietary): diatrizoate meglumine and diatrizoate sodium
Active ingredients: Diatrizoate meglumine — 660 mg/mLDiatrizoate sodium — 100 mg/mL
Dosage form: Solution
Route: Oral, Rectal
Labeler: Guardian Drug CompanyNDC labeler code 53041
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214201
Marketing start: Dec 18, 2019
Listing expires: Dec 31, 2026
Other FDA classes: X-Ray Contrast Activity (Mechanism)X-Ray Contrast Activity (Mechanism)
Identifiers: Product ID 53041-688_9cfdb214-1075-4449-9a01-f04cf5d0edfeSPL ID 9cfdb214-1075-4449-9a01-f04cf5d0edfeSPL set ID e9da4d3d-d0ca-44f7-aaeb-ae49c3839775UNII V5403H8VG7, 3X9MR4N98U
Pharmacologic class: Radiographic Contrast Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N453041068803 followed by a unit qualifier and the quantity

Package 53041-0688-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 22, 2020.

Indications (excerpt from the label)

INDICATIONS & USAGE Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficie…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53041-688

What is NDC 53041-688?: 53041-688 is the product NDC for Diatrizoate Meglumine and Diatrizoate Sodium, Diatrizoate meglumine 660 mg/mL; Diatrizoate sodium 100 mg/mL solution, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diatrizoate Meglumine and Diatrizoate Sodium.
What is the active ingredient?: Diatrizoate meglumine, Diatrizoate sodium.
Who is the labeler?: Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diatrizoate Meglumine and Diatrizoate Sodium?: 2 other product NDCs are listed under this name. See all Diatrizoate Meglumine and Diatrizoate Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diatrizoate Meglumine and Diatrizoate Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diatrizoate Meglumine and Diatrizoate Sodium	Diatrizoate meglumine 660 mg/mL; Diatrizoate sodium 100 mg/mL	SolutionOral, Rectal	Camber Pharmaceuticals, Inc.	31722-019	31722-0019-3131722-0019-32
Diatrizoate Meglumine and Diatrizoate Sodium	Diatrizoate meglumine 660 mg/mL; Diatrizoate sodium 100 mg/mL	SolutionOral, Rectal	Guardian Drug Company	53041-690	53041-0690-0353041-0690-09

Other NDCs under ANDA 214201

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214201
Product	Strength	Form · route	Labeler	Product NDC
Diatrizoate Meglumine and Diatrizoate Sodium	Diatrizoate meglumine 660 mg/mL; Diatrizoate sodium 100 mg/mL	SolutionOral, Rectal	Guardian Drug Company	53041-690