What is NDC 63629-1765?

63629-1765 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Sulfamethoxazole, Trimethoprim.

Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sulfamethoxazole and Trimethoprim?

89 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sulfamethoxazole and Trimethoprim NDC 63629-1765

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-1765Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-1765Add 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
63629-1765-0	63629176500	21 TABLET in 1 BOTTLE (63629-1765-0)Marketed from Sep 17, 2010
63629-1765-1	63629176501	20 TABLET in 1 BOTTLE (63629-1765-1)Marketed from Oct 9, 2024
63629-1765-2	63629176502	14 TABLET in 1 BOTTLE (63629-1765-2)Marketed from Oct 9, 2024
63629-1765-3	63629176503	10 TABLET in 1 BOTTLE (63629-1765-3)Marketed from Oct 9, 2024
63629-1765-4	63629176504	28 TABLET in 1 BOTTLE (63629-1765-4)Marketed from Oct 9, 2024
63629-1765-5	63629176505	40 TABLET in 1 BOTTLE (63629-1765-5)Marketed from Oct 9, 2024
63629-1765-6	63629176506	6 TABLET in 1 BOTTLE (63629-1765-6)Marketed from Oct 9, 2024
63629-1765-7	63629176507	60 TABLET in 1 BOTTLE (63629-1765-7)Marketed from Oct 9, 2024
63629-1765-8	63629176508	30 TABLET in 1 BOTTLE (63629-1765-8)Marketed from Oct 9, 2024
63629-1765-9	63629176509	13 TABLET in 1 BOTTLE (63629-1765-9)Marketed from Oct 9, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076899
Marketing start: Sep 13, 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 63629-1765_a903d079-327d-475b-953f-045f458657e5SPL ID a903d079-327d-475b-953f-045f458657e5SPL set ID a174991a-53e7-c791-3cee-b706a48e0ec5RxCUI 198335UNII JE42381TNV, AN164J8Y0X
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

N463629176500 followed by a unit qualifier and the quantity

Package 63629-1765-00. 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 9, 2024.

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 and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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 susceptible s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-1765

What is NDC 63629-1765?: 63629-1765 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sulfamethoxazole and Trimethoprim.
What is the active ingredient?: Sulfamethoxazole, Trimethoprim.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sulfamethoxazole and Trimethoprim?: 89 other product NDCs are listed under this name. See all Sulfamethoxazole and Trimethoprim 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 Sulfamethoxazole and Trimethoprim NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-078	87441-0078-01
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Coupler LLC	67046-0295	67046-0295-03
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2580	55154-2580-00
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Northwind Health Company, LLC	82868-092	82868-0092-28
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL	SuspensionOral	American Health Packaging	60687-442	60687-0442-75
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-0853	00121-0853-20
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8607	68788-8607-04
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Northwind Health Company, LLC	51655-188	51655-0188-2051655-0188-5351655-0188-84+1 more
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Pharmasource Meds, LLC	82982-044	82982-0044-1482982-0044-20
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Northwind Health Company, LLC	51655-307	51655-0307-2051655-0307-2951655-0307-53+2 more

All 90 Sulfamethoxazole and Trimethoprim NDCs

Other NDCs under ANDA 076899

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

FDA NDC Directory listings under ANDA 076899
Product	Strength	Form · route	Labeler	Product NDC
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Proficient Rx LP	63187-782
Sulfamethox-TMP DSsulfamethoxazole, trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	PharmPak, Inc.	54348-625
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Major Pharmaceuticals	0904-2725
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-4850
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-4847
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-4848
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-271
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Northwind Health Company, LLC	51655-307
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-272
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-6901
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-6902
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-6904
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1	TabletOral	AvKARE	42291-758
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-271
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	AvKARE	42291-759
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-272
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Cardinal Health 107, LLC	55154-7895
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-7008
Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim	Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0001