What is NDC 61919-645?

61919-645 is the product NDC for Sulfameth/Trimeth-DS, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Sulfamethoxazole, Trimethoprim.

Direct_Rx, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sulfameth/Trimeth-DS?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sulfameth/Trimeth-DS NDC 61919-645 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61919-645Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61919-0645Add 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
61919-645-06	61919064506	6 TABLET in 1 BOTTLE (61919-645-06)Marketed from Aug 13, 2019
61919-645-30	61919064530	30 TABLET in 1 BOTTLE (61919-645-30)Marketed from Aug 13, 2019
61919-645-56	61919064556	56 TABLET in 1 BOTTLE (61919-645-56)Marketed from Aug 13, 2019
61919-645-60	61919064560	60 TABLET in 1 BOTTLE (61919-645-60)Marketed from Aug 13, 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): Sulfameth/Trimeth-DS
Generic name (nonproprietary): sulfameth/trimeth-ds
Active ingredients: Sulfamethoxazole — 800 mg/1Trimethoprim — 160 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_RxNDC labeler code 61919
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090624
Marketing start: Aug 13, 2019
Listing expires: Dec 31, 2027
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 61919-645_47e154aa-d636-469b-e063-6394a90ad9b9SPL ID 47e154aa-d636-469b-e063-6394a90ad9b9SPL set ID 90026ce8-3305-6272-e053-2995a90a57e0RxCUI 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

N461919064506 followed by a unit qualifier and the quantity

Package 61919-0645-06. 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 Jan 8, 2026.

Indications (excerpt from the label)

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 susceptible strains of th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-645

What is NDC 61919-645?: 61919-645 is the product NDC for Sulfameth/Trimeth-DS, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sulfameth/Trimeth-DS.
What is the active ingredient?: Sulfamethoxazole, Trimethoprim.
Who is the labeler?: Direct_Rx, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sulfameth/Trimeth-DS?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8121
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	QPharma, Inc.	42708-053
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-2198
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-2199
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-2200
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-2201
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-2479
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-5679
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-5680
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-5682
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	A-S Medication Solutions	50090-7399
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1	TabletOral	AvPAK	50268-728
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	Cardinal Health 107, LLC	55154-2580
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Quality Care Products LLC	55700-611
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-232
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-233
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	St. Mary's Medical Park Pharmacy	60760-541

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