NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3579Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3579Add 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 NDC11-digit (billing)PackageCopy
68071-3579-16807135790168071357901100 TABLET in 1 BOTTLE (68071-3579-1)Marketed from Feb 28, 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 — 400 mg/1Trimethoprim — 80 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090624
Marketing start
Listing expires
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 68071-3579_40980007-9cca-cbda-e063-6394a90a23b3SPL ID 40980007-9cca-cbda-e063-6394a90a23b3SPL set ID 1274cefb-0799-e2e4-e063-6394a90aad02UNII JE42381TNV, AN164J8Y0XUPC 0368071357912
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

N468071357901 followed by a unit qualifier and the quantity

Package 68071-3579-01. 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 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 68071-3579

What is NDC 68071-3579?
68071-3579 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. 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?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralUnit Dose Solutions, Inc.87441-07887441-0078-01
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralCoupler LLC67046-029567046-0295-03
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralCardinal Health 107, LLC55154-258055154-2580-00
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralNorthwind Health Company, LLC82868-09282868-0092-28
Sulfamethoxazole and TrimethoprimSulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mLSuspensionOralAmerican Health Packaging60687-44260687-0442-75
Sulfamethoxazole and TrimethoprimSulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-085300121-0853-20
Sulfamethoxazole and TrimethoprimSulfamethoxazole 80 mg/mL; Trimethoprim 16 mg/mLInjection, Solution, ConcentrateIntravenousTeva Parenteral Medicines, Inc.0703-951400703-9514-83
Sulfamethoxazole and TrimethoprimSulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-860768788-8607-04
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralNorthwind Health Company, LLC51655-18851655-0188-2051655-0188-5351655-0188-84+1 more
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralPharmasource Meds, LLC82982-04482982-0044-1482982-0044-20

All 91 Sulfamethoxazole and Trimethoprim NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralBryant Ranch Prepack71335-0762
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-541
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-196
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-7399
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralCardinal Health 107, LLC55154-2580
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralVERITYRX, LLC83939-0023
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-816
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralUnit Dose Solutions, Inc.87441-078
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralProficient Rx LP71205-810
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralCoupler LLC67046-0295
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-2198
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-2199
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralSportpharm LLC85766-015
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-2200
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-2201
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8121
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralProficient Rx LP63187-695
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralREMEDYREPACK INC.70518-0863
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralQPharma, Inc.42708-053
Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0002

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