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(from DailyMed)

Sulfamethoxazole and Trimethoprim 800; 160 mg; mg Tablet, 10-count

by Denton Pharma, Inc. DBA Northwind Pharmaceuticals · 10 TABLET in 1 BOTTLE, PLASTIC (70934-049-10)
NDC 70934-0049-10
🏷️ FDA NDC (as labeled) 70934-049-10 billing pads the product segment with a zero
This package
Contains10-count Pack sizes2 compare ↓
Also comes in: 20 tablets 70934-0049-20
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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

⚠️
Other active recalls for Sulfamethoxazole And Trimethoprim (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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
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 · 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Nov 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 70934-049-10
Product NDC 70934-049
11-digit billing NDC 70934004910
NCPDP billing unit EA — each (per item)
Application # ANDA090624
Established class (EPC) Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Su
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Nov 2024)
Route ORAL
Dosage form TABLET
Substance 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 70934-049-10 — a 5-3-2 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 product segment → 70934-0049-10. 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.

🏭 Manufacturer & labeler

LabelerDenton Pharma, Inc. DBA Northwind Pharmaceuticals
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA090624 (ANDA)
Labeler code70934
Product typeHuman Prescription Drug
Portfolio2 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
📗 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 tablets
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 mg 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 —
Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 53746-0272-01 Amneal 100 tablets $0.062 AB FDA listed —
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; 160 mg/1; mgthis 70934-0049-10 Denton 10 tablets — AB Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 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
70934-0049-10 You're viewing this 10 TABLET in 1 BOTTLE, PLASTIC (70934-049-10) 2018-06-04 Discontinued by firm
70934-0049-20 20 TABLET in 1 BOTTLE, PLASTIC (70934-049-20) 2017-12-05 Discontinued by firm

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 70934-0049-10?
NDC 70934-0049-10 is a 10-count package — 10 tablet in 1 bottle, plastic.
What is the difference between NDC 70934-0049-10 and NDC 70934-0049-20?
Both are Sulfamethoxazole and Trimethoprim 800; 160 mg; mg Tablet — the drug itself is identical. NDC 70934-0049-10 is the 10-count package, while NDC 70934-0049-20 is the 20 tablets package.
What NDC number is used to bill for this package of Sulfamethoxazole and Trimethoprim 800; 160 mg; mg Tablet?
Bill NDC 70934-0049-10 — the 11-digit billing format is 70934004910. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70934-049-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70934-0049-10, written without dashes as 70934004910. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70934-0049-10, the first segment (70934) is the labeler code FDA assigned to Denton Pharma, Inc. DBA Northwind Pharmaceuticals; the middle segment (0049) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 tablets (70934-0049-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Denton Pharma, Inc. DBA Northwind Pharmaceuticals is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 70927-0001-00 · Hmong 70934-0544-06 · Denton →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.