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Sulfamethoxazole and Trimethoprim 800 mg; 160 mg Tablet, 100-count — NDC 00904-2725-61 package photo

Sulfamethoxazole and Trimethoprim 800 mg; 160 mg Tablet, 100-count

by Major Pharmaceuticals · 100 BLISTER PACK in 1 CARTON (0904-2725-61) / 1 TABLET in 1 BLISTER PACK
NDC 00904-2725-61
🏷️ FDA NDC (as labeled) 0904-2725-61 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · Sep 2, 2025 — Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0624-2025
Class II · Sep 2, 2025 — Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0625-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Sulfamethoxazole And Trimethoprim (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 20, 2025 — Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. (Northwind Pharmaceuticals LLC) · FDA recall D-0654-2025
Class II · Aug 18, 2025 — Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. (Amneal Pharmaceuticals, LLC) · FDA recall D-0615-2025
Class I · Jun 2, 2025 — Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. (Amneal Pharmaceuticals, LLC) · FDA recall D-0488-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1059-2022

🆔 Identity & classification

FDA NDC (as labeled) 0904-2725-61
Product NDC 0904-2725
11-digit billing NDC 00904272561
NCPDP billing unit EA — each (per item)
RxCUI 198335
UNII JE42381TNV, AN164J8Y0X
Application # ANDA076899
SPL Set ID abe0d2d5-4879-4b4e-9b57-47ea83a17ba0
Established class (EPC) Sulfonamide Antimicrobial; Dihydrofolate Reductase Inhibitor Antibacterial
Mechanism of action Cytochrome P450 2C9 Inhibitors; Dihydrofolate Reductase Inhibitors; Cytochrome P450 2C8 Inhibitors; Organic Cation Transporter 2 Inhibitors
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-09-13
Marketing end 2027-03-31
Route ORAL
Dosage form TABLET
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
GPI-14 16990002300320
GPI class Sulfamethoxazole-Trimethoprim
GCN Seq No 009396
GCN 90163
HICL code 004071
Ingredient (HICL) Sulfamethoxazole/Trimethoprim
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2A
Therapeutic class — specific (HIC3) Absorbable Sulfonamide Antibacterial Agents
AHFS code 08:12.20.00
AHFS class Sulfonamides
FDB label name SULFAMETHOXAZOLE-TMP DS TABLET
FDB brand name Sulfamethoxazole-Trimethoprim
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0904-2725-61 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00904-2725-61. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Sulfonamide Antimicrobial class.

Pharmacologic class Sulfonamide Antimicrobial
Drug family (ATC) Intermediate-acting sulfonamides
How it works Cytochrome P450 2C9 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderAMNEAL PHARMACEUTICALS NY LLC
FDA applicationANDA076899 (ANDA)
Labeler code00904
First marketedSep 2010
Product typeHuman Prescription Drug
Portfolio629 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SULFAMETHOXAZOLE-TMP DS TABLET Ingredient Sulfamethoxazole/Trimethoprim
📖 What it is MedlinePlus · NLM

Co-trimoxazole (a combination of sulfamethoxazole and trimethoprim) is used to treat certain infections that are caused by bacteria. It also is used to treat 'travelers' diarrhea. Co-trimoxazole is in a class of medications called sulfonamides. It works by stopping the growth of bacteria. Antibiotics will not work to kill viruses.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The IV form is used when your infection is serious enough that you need the medication working quickly and reliably, or when you're not able to take pills by mouth right now. Once...
  • Why am I getting this antibiotic through an IV instead of just taking a pill?
  • The most common things people notice are nausea, vomiting, and skin rashes — those are uncomfortable but not usually dangerous on their own. What you want to report right away is a...
  • What side effects should I actually expect, and which ones should make me call someone?
📖 Read our full Sulfamethoxazole / Trimethoprim guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeOval
ImprintIP;272
Size19 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.045 $4.48 / 100 tablet
Medicaid paysCMS SDUD · 12 mo $1.52 $151.58 / 100 tablet
Medicare drug plans payPart D · Q2 2026 $0.1395 $13.95 / 100 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.082 $0.045
▼ Down 28% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mgthis 00904-2725-61 Major 100 tablets $0.045 AB Availability likely —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 57237-0233-01 Rising 100 tablets $0.045 AB Availability likely —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 60687-0614-01 American 100 tablets $0.045 AB Availability likely —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 62135-0898-18 Chartwell 180 tablets $0.045 AB Availability likely —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 65862-0420-01 Aurobindo 100 tablets $0.045 AB Availability likely —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 53489-0146-01 Sun 100 tablets $0.047 AB FDA listed +5%
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 53746-0272-01 Amneal 100 tablets $0.062 AB FDA listed +39%
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 00615-8121-10 NCS 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 42291-0759-01 AvKARE 100 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 42708-0053-20 QPharma, 20 tablets — AB FDA listed —
Bactrim DS 800 mg/1; 160 mg 49708-0146-01 Sun 100 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-2198-00 A-S 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-2199-00 A-S 40 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-2200-00 A-S 20 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-2201-00 A-S 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-2479-02 A-S 60 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-4847-00 A-S 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-4848-02 A-S 60 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-4850-00 A-S 40 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-5679-00 A-S 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-5680-02 A-S 60 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-5682-00 A-S 40 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-6901-00 A-S 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-6902-02 A-S 60 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-6904-00 A-S 40 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-7008-00 A-S 100 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-7393-01 A-S 14 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 50090-7399-00 A-S 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 51655-0188-20 Northwind 20 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 51655-0307-20 Northwind 20 tablets — AB FDA listed —
Sulfamethox-TMP DS 800 mg/1; 160 mg 54348-0625-06 PharmPak, 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 55154-2580-00 Cardinal 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 55154-7895-00 Cardinal 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 55700-0611-06 Quality 6 tablets — AB Discontinued —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 60429-0259-01 Golden 100 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 60760-0541-14 St. 14 tablets — AB FDA listed —
Sulfameth/Trimeth-DS 800 mg/1; 160 mg 61919-0645-28 Direct_Rx 28 tablets — AB Discontinued —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 61971-0120-01 Vista 100 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 63187-0008-06 Proficient 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 63187-0695-06 Proficient 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 63187-0782-06 Proficient 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 63629-1765-00 Bryant 21 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 65162-0272-01 Amneal 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 66267-0196-06 NuCare 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 66267-0816-02 NuCare 2 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 67046-0295-03 Coupler 30 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 68071-4710-01 NuCare 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 68071-4948-02 NuCare 2 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 68788-7622-01 Preferred 10 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 69043-0011-01 Cronus 100 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 70518-0863-02 REMEDYREPACK 100 tablets — AB Discontinued —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 70518-2604-00 REMEDYREPACK 14 tablets — AB Discontinued —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 70518-3432-00 REMEDYREPACK 10 tablets — AB Discontinued —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 70934-0544-06 Denton 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 71205-0810-06 Proficient 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 71335-0762-00 Bryant 21 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 72789-0018-02 PD-Rx 2 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 72789-0064-06 PD-Rx 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 76420-0064-06 Asclemed 6 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim DS 160 mg/1; 800 mg 80425-0001-01 Advanced 14 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim DS 800 mg/1; 160 mg 80425-0002-01 Advanced 14 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim DS 160 mg/1; 800 mg 80425-0003-01 Advanced 14 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 82868-0092-28 Northwind 28 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 82982-0044-14 Pharmasource 14 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 83939-0023-01 VERITYRX, 1 tablet — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 85766-0015-01 Sportpharm 100 tablets — AB FDA listed —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 87441-0078-01 Unit 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2010
On the market since
Sep 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00904-2725-61, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7K
Units reimbursed last 4 qtrs
28.4K
Gross reimbursed last 4 qtrs
$43.1K
Avg / prescription
$6.13
Avg / unit
$1.5158
Latest quarter Q4 2025
1.4KRx
Medicaid pays / ea
$1.5158
gross reimbursed
vs
NADAC / ea
$0.0448
acquisition cost
=
Spread
+$1.4710
+3283% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
53% FFS 47% MCO
Fee-for-service · 3,737 Rx Managed care · 3,282 Rx
State Medicaid map
Alaska: 5,950 units · 812 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 1,284 units · 113 per 100k residents MT North Dakota: 19 units · 2.4 per 100k residents ND Minnesota: 44 units · 0.8 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,678 units · 8.6 per 100k residents NY Vermont: no data reported VT New Hampshire: 629 units · 44.9 per 100k residents NH Oregon: 251 units · 5.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 184 units · 20.0 per 100k residents SD Iowa: no data reported IA Illinois: 85 units · 0.7 per 100k residents IL Indiana: 150 units · 2.2 per 100k residents IN Ohio: 275 units · 2.3 per 100k residents OH Pennsylvania: 158 units · 1.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 380 units · 5.4 per 100k residents MA California: 8,717 units · 22.4 per 100k residents CA Utah: 256 units · 7.5 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 1,861 units · 30.0 per 100k residents MO Kentucky: 640 units · 14.1 per 100k residents KY West Virginia: no data reported WV Virginia: 241 units · 2.8 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 107 units · 5.1 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,836 units · 25.8 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 1,354 units · 46.1 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 943 units · 139 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: 659 units · 2.9 per 100k residents FL
Units reimbursed · per 100k residents
0.7812
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Alaska 812 /100k
2 D.C. 139 /100k
3 Montana 113 /100k
4 Mississippi 46.1 /100k
5 New Hampshire 44.9 /100k
6 Missouri 30.0 /100k
7 Tennessee 25.8 /100k
8 California 22.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sulfamethoxazole and Trimethoprim — the ingredient across all brands.

Top reported reactions

Pyrexia6,296
Fatigue5,409
Diarrhoea4,953
Nausea4,886
Rash4,491
Dyspnoea4,480
Pain4,112

Reporter sex

0 reports

Serious outcomes

Death10,340
Life-threatening6,805
Disabling3,167
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,935 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00904-2725-61 You're viewing this 100 BLISTER PACK in 1 CARTON (0904-2725-61) / 1 TABLET in 1 BLISTER PACK 2009-08-11 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~2 min read ▾

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 strains of the following organisms: Escherichia coli , Klebsiella species, Enterobacter species, Morganella morganii , Proteus mirabilis and Proteus vulgaris . It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents.

To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent.

Shigellosis For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli .

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age. Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.

Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage: Children 2 months of age or older: Weight Dose – every 12 hours lb kg Tablets 22 10 - 44 20 1 66 30 1 1/2 88 40 2 or 1 DS tablet For Patients with Impaired Renal Function When renal function is impaired, a reduced dosage should be employed using the following table: Creatinine Clearance (mL/min) Recommended Dosage Regimen Above 30 Usual standard regimen 15 to 30 1/2 the usual regimen Below 15 Use not recommended Acute Exacerbations of Chronic Bronchitis in Adults The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet, or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.

Pneumocystis jirovecii Pneumonia Treatment Adults and Children: The recommended dosage for treatment of patients with documented Pneumocystis jirovecii pneumonia is 75 mg/kg to 100 mg/kg sulfamethoxazole and 15 mg/kg to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days. 12 The following table is a guideline for the upper limit of this dosage: Weight Dose – every 6 hours lb kg Tablets 18 8 - 35 16 1 53 24 1 1/2 70 32 2 or 1 DS tablet 88 40 2 1/2 106 48 3 or 1 1/2 DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 2 1/2 DS tablets For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.

Prophylaxis Adults: The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim double strength tablet daily. 13 Children: For children, the recommended dose is 750 mg/m 2 /day sulfamethoxazole with 150 mg/m 2 /day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1,600 mg sulfamethoxazole and 320 mg trimethoprim.

14 The following table is a guideline for the attainment of this dosage in children: Body Surface Area Dose – every 12 hours (m 2 ) Tablets 0.26 - 0.53 1/2 1.06 1 Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.

⛔ Contraindications 69 words ▾

CONTRAINDICATIONS Sulfamethoxazole and trimethoprim is contraindicated in the following situations: • known hypersensitivity to trimethoprim or sulfonamides • history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides • documented megaloblastic anemia due to folate deficiency • pediatric patients less than 2 months of age • marked hepatic damage • severe renal insufficiency when renal function status cannot be monitored • concomitant administration with dofetilide (see PRECAUTIONS ).

⚠️ Warnings ~2 min read ▾

WARNINGS Embryofetal Toxicity Some epidemiologic studies suggest that exposure to sulfamethoxazole and trimethoprim during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, and club foot. If sulfamethoxazole and trimethoprim is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazards to the fetus (see PRECAUTIONS ).

Hypersensitivity and Other Serious or Fatal Reactions Fatalities and serious adverse reactions including severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim (see ADVERSE REACTIONS ).

Hypersensitivity Reactions of the Respiratory Tract Cough, shortness of breath and pulmonary infiltrates potentially representing hypersensitivity reactions of the respiratory tract have been reported in association with sulfamethoxazole and trimethoprim treatment. Respiratory Failure Other severe pulmonary adverse reactions occurring within days to week of sulfamethoxazole and trimethoprim initiation and resulting in prolonged respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO), lung transplantation or death have also been reported in patients and otherwise healthy individuals treated with sulfamethoxazole and trimethoprim products.

Circulatory Shock Circulatory shock with fever, severe hypotension, and confusion requiring intravenous fluid resuscitation and vasopressors has occurred within minutes to hours of re-challenge with sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim, in patients with history of recent (days to weeks) exposure to sulfamethoxazole and trimethoprim. Management of Hypersensitivity and Other Serious Reactions Sulfamethoxazole and trimethoprim should be discontinued at the first appearance of skin rash or any sign of a serious adverse reaction.

A skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AFND, AGEP, hepatic necrosis, or serious blood disorders (see PRECAUTIONS and ADVERSE REACTIONS ). Clinical signs, such as rash, pharyngitis, fever, arthralgia, cough, chest pain, dyspnea, pallor, purpura or jaundice may be early indications of serious reactions. Hemophagocytic Lymphohistiocytosis Cases of hemophagocytic lymphohistiocytosis (HLH) have been reported in patients treated with sulfamethoxazole-trimethoprim.

HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation. Signs and symptoms of HLH may include fever, hepatosplenomegaly, rash, lymphadenopathy, neurologic symptoms, cytopenias, high serum ferritin, hypertriglyceridemia, and liver enzyme and coagulation abnormalities. If HLH is suspected, discontinue sulfamethoxazole and trimethoprim immediately and institute appropriate management.

Thrombocytopenia Sulfamethoxazole and trimethoprim-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Thrombocytopenia usually resolves within a week upon discontinuation of sulfamethoxazole and trimethoprim.

Streptococcal Infections and Rheumatic Fever The sulfonamides should not be used for treatment of group A β-hemolytic streptococcal infections. In an established infection, they will not erad…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The following adverse reactions associated with the use of sulfamethoxazole and trimethoprim were identified in clinical trials, post-marketing or published reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria).

Fatalities and serious adverse reactions, including severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim (see WARNINGS).

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura. Allergic/Immune Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria, rash, periarteritis nodosa, hemophagocytic lymphohistiocytosis (HLH), systemic lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized erythematous pustulosis (AGEP), and acute febrile neutrophilic dermatosis (AFND) (see WARNINGS ).

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia. Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, renal insufficiency, oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine. Metabolic and Nutritional: Hyperkalemia, hyponatremia (see PRECAUTIONS: Electrolyte Abnormalities ), metabolic acidosis.

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache. Psychiatric: Hallucinations, depression, apathy, nervousness. Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents.

Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred. Musculoskeletal: Arthralgia, myalgia, rhabdomyolysis.

Respiratory: Cough, shortness of breath and pulmonary infiltrates, acute eosinophilic pneumonia, acute and delayed lung injury, interstitial lung disease, acute respiratory failure (see WARNINGS ). Cardiovascular System: QT prolongation resulting in ventricular tachycardia and torsades de pointes , circulatory shock (see WARNINGS ) . Miscellaneous: Weakness, fatigue, insomnia.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Acute The amount of a single dose of sulfamethoxazole and trimethoprim that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted.

Blood dyscrasias and jaundice are potential late manifestations of overdosage. Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression. General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids, and the administration of intravenous fluids if urine output is low and renal function is normal.

Acidification of the urine will increase renal elimination of trimethoprim. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications.

Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating sulfamethoxazole and trimethoprim. Chronic Use of sulfamethoxazole and trimethoprim at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, the patient should be given leucovorin 5 mg to 15 mg daily until normal hematopoiesis is restored.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. Both sulfamethoxazole and trimethoprim exist in the blood as unbound, protein-bound and metabolized forms; sulfamethoxazole also exists as the conjugated form. Sulfamethoxazole is metabolized in humans to at least 5 metabolites: the N 4 -acetyl-, N 4 -hydroxy-, 5-methylhydroxy-, N 4 -acetyl-5-methylhydroxy- sulfamethoxazole metabolites, and an N-glucuronide conjugate.

The formulation of N 4 -hydroxy metabolite is mediated via CYP2C9. Trimethoprim is metabolized in vitro to 11 different metabolites, of which, five are glutathione adducts and six are oxidative metabolites, including the major metabolites, 1- and 3-oxides and the 3- and 4-hydroxy derivatives. The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.

In vitro studies suggest that trimethoprim is a substrate of P-glycoprotein, OCT1 and OCT2, and that sulfamethoxazole is not a substrate of P-glycoprotein. Approximately 70% of sulfamethoxazole and 44% of trimethoprim are bound to plasma proteins. The presence of 10 mg percent sulfamethoxazole in plasma decreases the protein binding of trimethoprim by an insignificant degree; trimethoprim does not influence the protein binding of sulfamethoxazole.

Peak blood levels for the individual components occur 1 to 4 hours after oral administration. The mean serum half-lives of sulfamethoxazole and trimethoprim are 10 and 8 to 10 hours, respectively. However, patients with severely impaired renal function exhibit an increase in the half-lives of both components, requiring dosage regimen adjustment (see DOSAGE AND ADMINISTRATION section).

Detectable amounts of sulfamethoxazole and trimethoprim are present in the blood 24 hours after drug administration. During administration of 800 mg sulfamethoxazole and 160 mg trimethoprim b.i.d., the mean steady-state plasma concentration of trimethoprim was 1.72 mcg/mL. The steady-state mean plasma levels of free and total sulfamethoxazole were 57.4 mcg/mL and 68 mcg/mL, respectively.

These steady-state levels were achieved after three days of drug administration 1 . Excretion of sulfamethoxazole and trimethoprim is primarily by the kidneys through both glomerular filtration and tubular secretion. Urine concentrations of both sulfamethoxazole and trimethoprim are considerably higher than are the concentrations in the blood.

The average percentage of the dose recovered in urine from 0 to 72 hours after a single oral dose of sulfamethoxazole and trimethoprim is 84.5% for total sulfonamide and 66.8% for free trimethoprim. Thirty percent of the total sulfonamide is excreted as free sulfamethoxazole, with the remaining as N 4 -acetylated metabolite. 2 When administered together as sulfamethoxazole and trimethoprim, neither sulfamethoxazole nor trimethoprim affects the urinary excretion pattern of the other.

Both sulfamethoxazole and trimethoprim distribute to sputum, vaginal fluid and middle ear fluid; trimethoprim also distributes to bronchial secretion, and both pass the placental barrier and are excreted in human milk. Pharmacokinetics in Pediatric Patients A simulation conducted with data from a pharmacokinetic study in 153 infants and children demonstrated that mean steady-state AUC and maximum plasma concentration of trimethoprim and sulfamethoxazole would be comparable between pediatric patients 2 months to 18 years receiving 8/40 (trimethoprim/ sulfamethoxazole) mg/kg/day divided every 12 hours and adult patients receiving 320/1,600 (trimethoprim/ sulfamethoxazole) mg/day.

Pharmacokinetics in Geriatric Patients The pharmacokinetics of sulfamethoxazole 800 mg and trimethoprim 160 mg were studied in 6 geriatric subjects (mean age: 78.6 years) and 6 young healthy subjects (mean age: 29.3 years) using a non-US approved formulation. Pharmacokinetic values for sulfamethoxazole in geriatric subjects were similar to those observed in young adu…

📦 How Supplied / Storage and Handling 100 words ▾

HOW SUPPLIED Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim Tablets USP, DS (double strength) 800 mg/160 mg , are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side. They are available as follows: Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-2725-61 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

📋 Description 132 words ▾

DESCRIPTION Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole is N 1 -(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10 H 11 N 3 O 3 S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula: Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14 H 18 N 4 O 3 .

It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula: Inactive ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate. lk uy

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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