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Doxycycline Hyclate 100 mg Tablet, Film Coated, 28-count — NDC 83112-0100-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doxycycline Hyclate 100 mg Tablet, Film Coated, 28-count — NDC 83112-100-28 (Billing 83112-0100-28)

by Health Department, Oklahoma State · 28 TABLET, FILM COATED in 1 PACKET

This is a package of 28 tablets of Doxycycline Hyclate 100 mg Tablet, Film Coated from Health Department, Oklahoma State, marketed since Mar 2025 and currently FDA-listed.

NDC 83112-0100-28
🏷️ FDA NDC (as labeled) 83112-100-28 billing pads the product segment with a zero
This package
Contains28-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.2471/unit — full pricing hub ↓
Product page 83112-0100-00 Also comes in: 14 tablets 83112-100-00 14 tablets 83112-100-14 20 tablets 83112-100-20 42 tablets 83112-100-42 56 tablets 83112-100-56
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

⚠️
Other active recalls for Doxycycline Hyclate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 29, 2025 — Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. (Acella Pharmaceuticals, LLC) · FDA recall D-0014-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83112-100-28
Product NDC 83112-100
11-digit billing NDC 83112010028
RxCUI 1649988, 1650143
UNII 19XTS3T51U
Application # ANDA062269
SPL Set ID f39365f9-eb64-00cb-e053-2995a90a8d80
Established class (EPC) Tetracycline-class Drug
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-07
Route ORAL
Dosage form TABLET, FILM COATED
Substance DOXYCYCLINE HYCLATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1649988
Why two NDCs? The FDA registers this code as 83112-100-28 — 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 → 83112-0100-28. 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 Tetracycline-class Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Tetracyclines
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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for bacterial infections such as rickettsial infections, sexually transmitted infections, respiratory tract infections and eye infections. Some products are als...
  • Take it exactly as your prescriber and label say. Swallow capsules with a full glass of water and avoid taking them right before lying down. For one capsule product, take it at lea...
  • Diarrhea, nausea, vomiting, stomach upset and loss of appetite are the most common. You may also sunburn much more easily, so cover up and avoid tanning beds. Call me or your docto...
  • Call right away for severe or watery diarrhea, a blistering or peeling rash, headache with vision changes, trouble swallowing, or signs of an allergic reaction. Diarrhea can show u...
📖 Read our full Doxycycline guide →
7
Nutrient depletion considerations

Doxycycline Hyclate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxycycline Hyclate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 · Q2 2026 $0.2471 $6.92 / 28 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83112-0100-00 83112-100-00 Main listing 14 TABLET, FILM COATED in 1 PACKET 2025-03-07 — Active
83112-0100-14 83112-100-14 14 TABLET, FILM COATED in 1 PACKET 2025-03-07 — Active
83112-0100-20 83112-100-20 20 TABLET, FILM COATED in 1 PACKET 2025-03-07 — Active
83112-0100-28 You're viewing this 28 TABLET, FILM COATED in 1 PACKET 2025-03-07 — Active
83112-0100-42 83112-100-42 42 TABLET, FILM COATED in 1 PACKET 2025-03-07 — Active
83112-0100-56 83112-100-56 56 TABLET, FILM COATED in 1 PACKET 2025-03-07 — Active

Pack size FAQ

What quantity is in this package?
This is a 28-count package — 28 tablet, film coated in 1 packet.
How does this package differ from NDC 83112-0100-00?
Both are Doxycycline Hyclate 100 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 28-count one, while NDC 83112-0100-00 is the 14 tablets package.
What NDC number is used to bill for this package of Doxycycline Hyclate 100 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxycycline Hyclate 100 mg 00143-2112-05 Hikma 500 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 00591-5553-05 Actavis 500 tablets $0.118 — Availability likely —
Doxycycline Hyclate 100 mg 00904-0430-04 Major 1 tablet $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 24658-0310-01 PURACAP 100 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 27808-0234-01 Cranbury 50 tablets $0.118 AB Availability likely —
Doxycycline 100 mg 42192-0501-05 Acella 500 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 50268-0279-15 AvPAK 1 tablet $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 53489-0120-02 Sun 50 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 62135-0626-01 Chartwell 100 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 62584-0693-21 American 1 tablet $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 43386-0794-01 Lupin 100 tablets $0.141 AB FDA listed —
Doxycycline Hyclate 100 mg 00615-8529-14 NCS 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 33342-0392-05 Macleods 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 40032-0794-01 Novel 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 42708-0173-20 QPharma, 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 42806-0310-01 Epic 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 46708-0353-20 Alembic 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-4981-00 A-S 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-6133-00 A-S 10 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 50090-6134-06 A-S 2 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 50090-7546-00 A-S 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7547-06 A-S 2 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7580-00 A-S 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7800-00 A-S 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 51407-0298-20 Golden 20 tablets — AB FDA listed —
Doxycycline 100 mg 55154-7128-00 Cardinal 1 tablet — AB FDA listed —
Doxycycline Hyclate 100 mg 55154-8079-00 Cardinal 1 tablet — AB FDA listed —
Doxycycline 100 mg 55289-0866-01 PD-Rx 100 tablets — AB FDA listed —
Doxycycline 100 mg 60429-0069-20 Golden 20 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 60760-0723-20 St. 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 62332-0353-20 Alembic 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 64380-0226-02 Strides 500 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-1431-01 RedPharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-1456-04 Redpharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-2075-02 Redpharm 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-2189-01 Redpharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-3466-07 NuCare 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-4836-07 NuCare 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-5265-02 NuCare 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68999-0626-02 Chartwell 20 tablets — AB FDA listed —
Doxycycline 100 mg 70518-3039-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3213-01 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3214-01 REMEDYREPACK 20 tablets — AB Discontinued —
Doxycycline 100 mg 70518-3363-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3869-00 REMEDYREPACK 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4510-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4544-00 REMEDYREPACK 20 tablets — AB FDA listed —
Doxycycline hyclate 100 mg 70771-1104-00 Zydus 1000 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71205-0697-10 Proficient 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-1686-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-2113-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-2639-01 Bryant 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-9718-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72162-2402-02 Bryant 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0127-14 direct 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0603-14 Direct_Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72578-0001-01 Viona 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0276-14 PD-Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0319-06 PD-Rx 6 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0419-14 PD-Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 82804-0070-14 Proficient 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 82804-0173-14 Proficient 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mgthis 83112-0100-28 Health 28 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 51655-0998-20 Northwind 20 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color blue / brown
ShapeRound
Imprint312;E
Size9 mm
ScoringNot scored
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.

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.

Manufacturer & labeler

LabelerHealth Department, Oklahoma State
Application holderEPIC PHARMA LLC
FDA applicationANDA062269 (ANDA)
Labeler code83112
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio8 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.

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.
⚠️ Warnings
⚠️ Warnings ~3 min read ▾

Doxycycline Hyclate 100 mg Warnings Section The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following the use of antibacterial drugs.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline. (See ADVERSE REACTIONS.) If severe skin reactions occur, doxycycline should be discontinued immediately and appropriate therapy should be instituted. Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline.

Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and doxycycline should be avoided because isotretinoin is also known to cause pseudotumor cerebri.

Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients wi…

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Doxycycline Hyclate — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Doxycycline Hyclate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.44M
Claims incl. refills
1.9M
Beneficiaries
1.6M
Spend / beneficiary
$12.09
Spend / claim
$10.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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) ✓ Available
Package photos ✓ Available
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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Health Department, Oklahoma State. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 14 tablets (83112-0100-00), 14 tablets (83112-0100-14), 20 tablets (83112-0100-20). 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?
Health Department, Oklahoma State 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.
← 83109-0002-01 · Institute
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.