NDC codes

FDA NDC Directory
Product NDC (as listed)42806-757Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42806-0757Add 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 NDC11-digit (billing)PackageCopy
42806-757-604280607576060 TABLET in 1 BOTTLE (42806-757-60)Marketed from Dec 15, 2021

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)
Sulfadiazine
Generic name (nonproprietary)
sulfadiazine
Active ingredients
Sulfadiazine — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
EPIC PHARMA, LLCNDC labeler code 42806
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040091
Marketing start
Listing expires
Other FDA classes
Sulfonamides (Chemical structure)
Identifiers
Product ID 42806-757_69f2d77c-8279-4524-93c2-f199e7973400SPL ID 69f2d77c-8279-4524-93c2-f199e7973400SPL set ID 8993651b-fff6-4e3f-9b60-78587bc9bceeRxCUI 198228UNII 0N7609K889UPC 0342806757604
Pharmacologic class
Sulfonamide Antibacterial

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442806075760 followed by a unit qualifier and the quantity

Package 42806-0757-60. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE sulfADIAZINE Tablets, USP are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Esch erichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus, Proteus mirabilis and P. vulgaris . Sulfadiazine should be used for urinary tract infections only after use of more soluble sulfonamides has been unsuccessful. Toxoplasmosis encephalitis in patients with and without acquired immunodeficiency syndrome, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-757

What is NDC 42806-757?
42806-757 is the product NDC for Sulfadiazine, Sulfadiazine 500 mg/1 tablet, listed with the FDA by EPIC PHARMA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sulfadiazine.
What is the active ingredient?
Sulfadiazine.
Who is the labeler?
EPIC PHARMA, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sulfadiazine?
1 other product NDC are listed under this name. See all Sulfadiazine 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 Sulfadiazine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
sulfADIAZINESulfadiazine 500 mg/1TabletOralChartwell RX, LLC62135-84262135-0842-60

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