Sulfamethoxazole and Trimethoprim NDC 63187-695

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-695Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0695Add 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
63187-695-06	63187069506	6 TABLET in 1 BOTTLE (63187-695-06)Marketed from Dec 1, 2016
63187-695-10	63187069510	10 TABLET in 1 BOTTLE (63187-695-10)Marketed from Dec 1, 2016
63187-695-14	63187069514	14 TABLET in 1 BOTTLE (63187-695-14)Marketed from Dec 1, 2016
63187-695-20	63187069520	20 TABLET in 1 BOTTLE (63187-695-20)Marketed from Dec 1, 2016
63187-695-28	63187069528	28 TABLET in 1 BOTTLE (63187-695-28)Marketed from Dec 1, 2016
63187-695-40	63187069540	40 TABLET in 1 BOTTLE (63187-695-40)Marketed from Dec 1, 2016

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): Sulfamethoxazole and Trimethoprim
Generic name (nonproprietary): sulfamethoxazole and trimethoprim
Active ingredients: Sulfamethoxazole — 800 mg/1Trimethoprim — 160 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090624
Marketing start: Feb 16, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)Sulfonamides (Chemical structure)
Identifiers: Product ID 63187-695_04942785-402c-49ca-a03d-6b69609673a7SPL ID 04942785-402c-49ca-a03d-6b69609673a7SPL set ID 29e83667-8d4a-49b7-9182-653cbfb2dee7RxCUI 198335UNII JE42381TNV, AN164J8Y0XUPC 0363187695101
Pharmacologic class: Dihydrofolate Reductase Inhibitor Antibacterial; Sulfonamide Antimicrobial

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

N463187069506 followed by a unit qualifier and the quantity

Package 63187-0695-06. 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 May 2, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due to sus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090624

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

FDA NDC Directory listings under ANDA 090624
Product	Strength	Form · route	Labeler	Product NDC
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	66267-816
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Coupler LLC	67046-0295
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Sportpharm LLC	85766-015
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-7393
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-018
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-7399
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	REMEDYREPACK INC.	70518-0863
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Pharmasource Meds, LLC	82982-044
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-064
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	American Health Packaging	60687-614
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4710
Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim	Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0003
Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0002
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-078
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Northwind Health Company, LLC	51655-188
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8121
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	VERITYRX, LLC	83939-0023
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1	TabletOral	Aurobindo Pharma Limited	65862-419
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Aurobindo Pharma Limited	65862-420
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-2201

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