What is NDC 70069-361?

70069-361 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 80 mg/mL; Trimethoprim 16 mg/mL injection, solution, concentrate, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Sulfamethoxazole, Trimethoprim.

Somerset Therapeutics, LLC, NDC labeler code 70069. 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?

90 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 70069-361

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-361Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0361Add 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	Copy
70069-361-10	7006903611070069036110	10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01)Marketed from Aug 29, 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): Sulfamethoxazole and Trimethoprim
Generic name (nonproprietary): sulfamethoxazole and trimethoprim
Active ingredients: Sulfamethoxazole — 80 mg/mLTrimethoprim — 16 mg/mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Somerset Therapeutics, LLCNDC labeler code 70069
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212231
Marketing start: Aug 29, 2019
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 70069-361_012dfac7-9b72-48a5-a364-e62bbe150cfeSPL ID 012dfac7-9b72-48a5-a364-e62bbe150cfeSPL set ID ebb570bb-6e5e-489e-875c-9e7b3a6d716aRxCUI 313137, 1809083UNII JE42381TNV, AN164J8Y0XUPC 0370069362105, 0370069363010, 0370069362013, 0370069361108, 0370069361016
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N470069036110 followed by a unit qualifier and the quantity

Package 70069-0361-10. 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 Jul 16, 2025.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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 the empiric selection of therapy. Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorgan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70069-361

What is NDC 70069-361?: 70069-361 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 80 mg/mL; Trimethoprim 16 mg/mL injection, solution, concentrate, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, 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?: Somerset Therapeutics, LLC, NDC labeler code 70069. 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?: 90 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 80 mg/mL; Trimethoprim 16 mg/mL	Injection, Solution, ConcentrateIntravenous	Teva Parenteral Medicines, Inc.	0703-9514	00703-9514-83
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

All 91 Sulfamethoxazole and Trimethoprim NDCs

Other NDCs under ANDA 212231

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

FDA NDC Directory listings under ANDA 212231
Product	Strength	Form · route	Labeler	Product NDC
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 80 mg/mL; Trimethoprim 16 mg/mL	Injection, Solution, ConcentrateIntravenous	Somerset Therapeutics, LLC	70069-362
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 80 mg/mL; Trimethoprim 16 mg/mL	Injection, Solution, ConcentrateIntravenous	Somerset Therapeutics, LLC	70069-363