Sulfamethoxazole and Trimethoprim 800; 160 mg; mg Tablet, 100-count
by American Health Packaging · 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-531-01) / 1 TABLET in 1 BLISTER PACK (60687-531-11)
NDC 60687-0531-01
🏷️ FDA NDC (as labeled)
60687-531-01
billing pads the product segment with a zero
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 →
⚠️
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 Sep 2023. 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)
60687-531-01
Product NDC
60687-531
11-digit billing NDC
60687053101
NCPDP billing unit
EA — each (per item)
Application #
ANDA076899
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 Sep 2023)
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 60687-531-01 — 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 → 60687-0531-01. 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
LabelerAmerican Health Packaging
Application holderAMNEAL PHARMACEUTICALS NY LLC
FDA applicationANDA076899 (ANDA)
Labeler code60687
Product typeHuman Prescription Drug
Portfolio673 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Sulfamethoxazole and Trimethoprim?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.062 | $6.24 / 100 tablet |
| 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. | |
NADAC price history (per ea) — tap or hover for the price & month
Flat over the last 12 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 00904-2725-61 | Major | 100 tablets | $0.045 | AB | Availability likely | save 28% |
| Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 57237-0233-01 | Rising | 100 tablets | $0.045 | AB | Availability likely | save 28% |
| Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 60687-0614-01 | American | 100 tablets | $0.045 | AB | Availability likely | save 28% |
| Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 62135-0898-18 | Chartwell | 180 tablets | $0.045 | AB | Availability likely | save 28% |
| Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 65862-0420-01 | Aurobindo | 100 tablets | $0.045 | AB | Availability likely | save 28% |
| Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 53489-0146-01 | Sun | 100 tablets | $0.047 | AB | FDA listed | save 25% |
| Sulfamethoxazole and Trimethoprim 800 mg/1; 160 mg 53746-0272-01 | Amneal | 100 tablets | $0.062 | AB | FDA listed | — |
| Sulfamethoxazole and Trimethoprim 800; 160 mg/1; mgthis 60687-0531-01 | American | 100 tablets | $0.062 | AB | Discontinued | — |
| 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 | — |
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
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60687-0531-01 You're viewing this | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-531-01) / 1 TABLET in 1 BLISTER PACK (60687-531-11) | 2020-02-11 | Discontinued by firm |
🧭 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) | ✓ Available |
| 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 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 60687-531-01, 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: 60687-0531-01, written without dashes as 60687053101. 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 60687-0531-01, the first segment (60687) is the labeler code FDA assigned to American Health Packaging; the middle segment (0531) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
American Health Packaging 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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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.