NDC codes

FDA NDC Directory
Product NDC (as listed)63187-782Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0782Add 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
63187-782-06631870782066 TABLET in 1 BOTTLE (63187-782-06)Marketed from Nov 1, 2016
63187-782-106318707821010 TABLET in 1 BOTTLE (63187-782-10)Marketed from Nov 1, 2016
63187-782-146318707821414 TABLET in 1 BOTTLE (63187-782-14)Marketed from Nov 1, 2016
63187-782-206318707822020 TABLET in 1 BOTTLE (63187-782-20)Marketed from Nov 1, 2016
63187-782-286318707822828 TABLET in 1 BOTTLE (63187-782-28)Marketed from Nov 1, 2016
63187-782-406318707824040 TABLET in 1 BOTTLE (63187-782-40)Marketed from Nov 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 LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076899
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 63187-782_5a945d95-78e5-470a-8567-5021043a3db6SPL ID 5a945d95-78e5-470a-8567-5021043a3db6SPL set ID 0df74ba1-1aa6-467c-92e7-6b017c7c6bceRxCUI 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

N463187078206 followed by a unit qualifier and the quantity

Package 63187-0782-06. 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 .

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 the empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-782

What is NDC 63187-782?
63187-782 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 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?
Proficient Rx LP, NDC labeler code 63187. 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
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 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
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralNorthwind Health Company, LLC51655-30751655-0307-2051655-0307-2951655-0307-53+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
ProductStrengthForm · routeLabelerProduct NDC
Sulfamethox-TMP DSsulfamethoxazole, trimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralPharmPak, Inc.54348-625
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralMajor Pharmaceuticals0904-2725
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-4850
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-4847
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-4848
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralBryant Ranch Prepack63629-1765
Sulfamethoxazole and TrimethoprimSulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-271
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralNorthwind Health Company, LLC51655-307
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-272
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-6901
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-6902
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-6904
Sulfamethoxazole and TrimethoprimSulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1TabletOralAvKARE42291-758
Sulfamethoxazole and TrimethoprimSulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1TabletOralAmneal Pharmaceuticals LLC65162-271
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralAvKARE42291-759
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralAmneal Pharmaceuticals LLC65162-272
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralCardinal Health 107, LLC55154-7895
Sulfamethoxazole and TrimethoprimSulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1TabletOralA-S Medication Solutions50090-7008
Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprimTrimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0001

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