Prescription drug · ANDA
Sulfadiazine NDC 42806-757
Sulfadiazine 500 mg/1 · Tablet · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-757-60 | 42806075760 | 60 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
N442806075760followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Sulfadiazine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| sulfADIAZINE | Sulfadiazine 500 mg/1 | TabletOral | Chartwell RX, LLC | 62135-842 | 62135-0842-60 |