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Minocycline Hydrochloride 75 mg Tablet, Film Coated, 100-count — NDC 59651-0338-01 package photo

Minocycline Hydrochloride 75 mg Tablet, Film Coated, 100-count

by Aurobindo Pharma Limited · 100 TABLET, FILM COATED in 1 CONTAINER (59651-338-01)
NDC 59651-0338-01
🏷️ FDA NDC (as labeled) 59651-338-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.3018 NADAC Per package$30.18 / 100 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $1.06/unit — full pricing hub ↓
Also comes in: 2800 tablets 59651-0338-27
On market Non-controlled
🗂️ Data synced Sep 13, 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 Minocycline Hydrochloride (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 · Jun 1, 2026 — Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis (Ascend Laboratories, LLC) · FDA recall D-0597-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 59651-338-01
Product NDC 59651-338
11-digit billing NDC 59651033801
NCPDP billing unit EA — each (per item)
SPL Set ID 799a9871-3249-471e-b88d-5d8f7d4b96ad
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-05-01
Dosage form TABLET, FILM COATED
Substance MINOCYCLINE HYDROCHLORIDE
GPI-14 04000040100307
GPI class Minocycline HCl
GCN Seq No 052057
GCN 19549
HICL code 004015
Ingredient (HICL) Minocycline Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name MINOCYCLINE HCL 75 MG TABLET
FDB brand name Minocycline Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 59651-338-01 — 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 → 59651-0338-01. 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

LabelerAurobindo Pharma Limited
Labeler code59651
First marketedMay 2020
Product typeDrug For Further Processing
Portfolio1,449 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 MINOCYCLINE HCL 75 MG TABLET Ingredient Minocycline Hcl
📖 What it is MedlinePlus · NLM

Minocycline is used to treat infections caused by bacteria and certain other infections spread by ticks, lice, mites, and infected animals. It is also used to treat acne and rosacea (a skin disease that causes redness, flushing, and pimples on the face). Minocycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne and rosacea by killing the bacteria that infects pores and by lowering the amount of oil on your skin that can cause acne. Antibiotics such as minocycline will not work f...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Good news — standard minocycline oral capsules and tablets can be taken with or without food, so you have flexibility there. The most important thing is to take it with a full glas...
  • Can I take my minocycline capsule or tablet with food, or does it have to be on an empty stomach?
  • The extended-release tablets for acne are typically taken once daily for 12 weeks. As with most acne treatments, you likely won't see dramatic results overnight — it takes time for...
  • I've been prescribed the extended-release minocycline tablets for acne. How long does it take to work, and how long do I take it?
📖 Read our full Minocycline guide →
11
Nutrient depletion considerations

Minocycline Hydrochloride may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Minocycline Hydrochloride 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.

💊 What it looks like

Color White
ShapeCapsule
Imprint100;M
Size13 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.

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

  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 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 $0.302 $30.18 / 100 tablets
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 $1.06 $105.68 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jul 2025 Jan 2026 Feb 2026 Mar 2026 $0.306 $0.302
▼ Down 1% over the last 4 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
Minocycline Hydrochloride 75 mg 13668-0486-01 Torrent 100 tablets $0.302 AB Availability likely —
Minocycline Hydrochloride 75 mgthis 59651-0338-01 Aurobindo 100 tablets $0.302 — Availability likely —
Minocycline Hydrochloride 75 mg 62135-0888-60 Chartwell 60 tablets $0.302 AB Availability likely —
Minocycline Hydrochloride 75 mg 64380-0155-01 Strides 100 tablets $0.302 AB Availability likely —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2020
On the market since
May 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Minocycline Hydrochloride — the ingredient across all brands.

Top reported reactions

Drug Intolerance969
Pain957
Rheumatoid Arthritis930
Nausea845
Rash821
Arthralgia811
Drug Hypersensitivity800

Age at onset

Neonate34
Infant2
Child8
Adolescent33
Adult772
Elderly332

Reporter sex

5,809 reports
Male · 30%
Female · 69%
Unknown · 2%

Serious outcomes

Life-threatening1,430
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 741 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 Per unit Per pack Marketing startStatus
59651-0338-01 You're viewing this 100 TABLET, FILM COATED in 1 CONTAINER (59651-338-01) $0.3018 / ea $30.18 2020-05-01 Active
59651-0338-27 2800 TABLET, FILM COATED in 1 BAG (59651-338-27) — — — Active

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

Pack size FAQ

What quantity is in NDC 59651-0338-01?
NDC 59651-0338-01 is a 100-count package — 100 tablet, film coated in 1 container.
What is the difference between NDC 59651-0338-01 and NDC 59651-0338-27?
Both are Minocycline Hydrochloride 75 mg Tablet, Film Coated — the drug itself is identical. NDC 59651-0338-01 is the 100-count package, while NDC 59651-0338-27 is the 2800 tablets package.
What NDC number is used to bill for this package of Minocycline Hydrochloride 75 mg Tablet, Film Coated?
Bill NDC 59651-0338-01 — the 11-digit billing format is 59651033801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 59651-338-01, 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: 59651-0338-01, written without dashes as 59651033801. 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 59651-0338-01, the first segment (59651) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0338) 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.
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 Aurobindo Pharma Limited. 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 1 other package presentation of this same product, including 2800 tablets (59651-0338-27). 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?
Aurobindo Pharma Limited 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.
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 FDA label FDA SPL

The complete FDA label for this product, 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 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Minocycline hydrochloride tablets are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by Rickettsiae . Respiratory tract infections caused by Mycoplasma pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis .

Psittacosis (Ornithosis) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis .

Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis . Chancroid caused by Haemophilus ducreyi Plague due to Yersinia pestis .

Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus.

Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Calymmatobacterium granulomatis.

Minocycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes . Shigella species.

Acinetobacter species. Respiratory tract infection caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species.

Minocycline hydrochloride tablets are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory tract infections caused by Streptococcus pneumoniae Skin and skin structure infections caused by Staphylococcus aureus . (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.

Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum . Yaws caused by Treponema pallidum subspecies pertenue .

Listeriosis due to Listeria monocytogenes . Anthrax due to Bacillus anthracis . Vincent’s infection caused by Fusobacterium fusiforme .

Actinomycosis caused by Actinomyces israelii . Infections caused by Clostridium species. In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides.

In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate the meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment.

It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection . Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum .

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets and other antibacterial drugs, minocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly…

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride tablets may be taken with or without food (see CLINICAL PHARMACOLOGY ).

Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The tablets should be swallowed whole. For Pediatric Patients Above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.

Adults The usual dosage of minocycline hydrochloride tablets is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg tablets may be given initially followed by one 50 mg tablet four times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of four days, with post-therapy cultures within 2 to 3 days.

In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.

In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for five days. Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum : 100 mg orally, every 12 hours for at least seven days.

Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CL CR <80mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted.

The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS ).

⛔ Contraindications 26 words ▾

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.

⚠️ Warnings ~3 min read ▾

WARNINGS MINOCYCLINE HYDROCHLORIDE TABLETS, LIKE OTHER TETRACYCLINE- CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. 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 drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six 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 been noted in animals treated early in pregnancy. Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use.

Fixed drug eruptions have occurred with minocycline and other tetracyclines. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed with other tetracyclines (see ADVERSE REACTIONS ). If severe skin reactions occur, discontinue minocycline hydrochloride tablets immediately and institute appropriate therapy.

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours (see DOSAGE AND ADMINISTRATION ).

If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.

Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline hydrochloride, 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 antibiotic use. 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 antibiotic use not directed against C. difficile may need to be discontinued. A…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines. Body as a whole: Fever, and discoloration of secretions.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ).

Genitourinary: Vulvovaginitis. Hepatic toxicity: Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS ).

Skin: Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, and vasculitis. Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported.

Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported.

Photosensitivity is discussed above (see WARNINGS ). Pigmentation of the skin and mucous membranes has been reported. Respiratory: Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis.

Renal toxicity: Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related (see WARNINGS ). Reversible acute renal failure has been reported.

Musculoskeletal: Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling. Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis/anaphylactoid reaction (including shock and fatalities), anaphylactoid purpura, myocarditis, pericarditis, exacerbation of systemic lupus erythematosus and pulmonary infiltrates with eosinophilia have been reported. A transient lupus-like syndrome and serum sickness-like reactions have also been reported.

Blood: Agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have been reported. Central Nervous System: Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo. Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported (see PRECAUTIONS-General ).

Headache has also been reported. Other: Thyroid cancer has been reported in the post-marketing setting in association with minocycline products. When minocycline therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered.

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. Cases of abnormal thyroid function have been reported. Tooth discoloration in children less than 8 years of age, and also in adults, has been reported (see WARNINGS ).

Oral cavity discoloration (including tongue, lip, and gum) have been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride. The following syndromes have been reported.

In some cases involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately: Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present.

Lupus-like syndrome consisting of positive antinuclear antibody;…

🔄 Drug Interactions 133 words ▾

Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy.

Each drug alone has been associated with pseudotumor cerebri (see PRECAUTIONS ). Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

🔄 Drug / Laboratory Test Interactions 19 words ▾

Drug/ Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

🤰 Pregnancy 126 words ▾

Pregnancy Teratogenic Effects: Pregnancy Category D (see WARNINGS ). All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women.

Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

If minocycline 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. Nonteratogenic Effects: (see WARNINGS ).

🧒 Pediatric Use 27 words ▾

Pediatric Use Minocycline is not recommended for use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS ).

🧓 Geriatric Use 74 words ▾

Geriatric Use Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS , DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 45 words ▾

OVERDOSAGE The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Following a single dose of one 100 mg tablet of minocycline hydrochloride administered to 28 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 3 hours (average 1.71 hours) and ranged from 491.71 to 1292.70 ng/mL (average 758.29 ng/mL). The serum half-life in the normal volunteers ranged from 11.38 to 24.31 hours (average 17.03 hours). When minocycline hydrochloride tablets were given concomitantly with a meal, which included dairy products, the extent of absorption of minocycline hydrochloride tablets was slightly decreased (6%).

The peak plasma concentrations were slightly decreased (12%) and delayed by 1.09 hours when administered with food, compared to dosing under fasting conditions. Minocycline hydrochloride may be administered with or without food. In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction.

The urinary and fecal recovery of minocycline when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines. Microbiology The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have similar antimicrobial spectra of activity against a wide range of gram-positive and gram-negative organisms.

Cross-resistance of these organisms to tetracycline is common. Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: AEROBIC GRAM-POSITIVE MICROORGANISMS Because many strains of the following gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended. Tetracycline antibiotics should not be used for streptococcal diseases unless the organism has been demonstrated to be susceptible.

Tetracyclines are not the drug of choice in the treatment of any type of staphylococcal infection. Bacillus anthracis a Listeria monocytogenes a Staphylococcus aureu s Streptococcus pneumoniae AEROBIC GRAM-NEGATIVE MICROORGANISMS Bartonella bacilliformi s Brucella species Calymmatobacterium granulomati s Campylobacter fetus Francisella tularensi s Haemophilus ducrey i Vibrio cholerae Yersinia pesti s Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility tests are especially recommended.

Acinetobacter species Enterobacter aerogene s Escherichia col i Haemophilus influenza e Klebsiella species Neisseria gonorrhoeae a Neisseria meningitidis a Shigella species “OTHER” MICROORGANISMS Actinomyces species a Borrelia recurrentis Chlamydia psittaci Chlamydia trachomatis Clostridium species a Entamoeba species Fusobacterium nucleatum subspecies fusiforme a Mycobacterium marinum Mycoplasma pneumonia e Propionibacterium acne s Rickettsia e Treponema pallidum subspecies pallidum a Treponema pallidum subspecies pertenue a Ureaplasma urealyticum a.

When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections caused by the cited microorganisms. Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 192 words ▾

HOW SUPPLIED Minocycline hydrochloride tablets, USP are supplied as aqueous film-coated tablets containing minocycline hydrochloride USP equivalent to 50 mg, 75 mg and 100 mg minocycline. Minocycline Hydrochloride Tablets, USP 50 mg are white, unscored, modified capsule shaped, coated tablet debossed with “50” on one side and “M” on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 50 mg minocycline, supplied as follows: Bottle of 100 NDC 59651-337-01 Minocycline Hydrochloride Tablets, USP 75 mg are white, unscored, modified capsule shaped, coated tablet debossed with “75” on one side and “M” on the other side.

Each tablet contains minocycline hydrochloride USP equivalent to 75 mg minocycline, supplied as follows: Bottle of 100 NDC 59651-338-01 Minocycline Hydrochloride Tablets, USP 100 mg are white, unscored, modified capsule shaped, coated tablet debossed with “100” on one side and “M” on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 100 mg minocycline, supplied as follows: Bottle of 50 NDC 59651-339-50 Store at 20 to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature] Protect from light, moisture, and excessive heat.

Dispense in a tight, light-resistant container as defined in the USP.

📋 Description 75 words ▾

DESCRIPTION Minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: Minocycline hydrochloride tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, 50 mg, 75 mg and 100 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate and titanium dioxide.

Chemical Structure

💬 Information for Patients ~1 min read ▾

Information For Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported with use of minocycline.

Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy (see WARNINGS ). Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective (see Drug Interactions ). Patients should be counseled that antibacterial drugs including minocycline hydrochloride tablets should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride tablets or other antibacterial drugs in the future.

Unused supplies of tetracycline antibiotics should be discarded by the expiration date.

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Minocycline Hydrochloride (min’’ oh sye’ kleen hye’’ droe klor’ ide) Tablets, USP 50 mg, 75 mg, and 100 mg Read the Patient Information that comes with minocycline hydrochloride tablets before you or a family member starts taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

What are minocycline hydrochloride tablets? Minocycline hydrochloride tablets are a tetracycline-class antibiotic medicine. Minocycline hydrochloride tablets are used to treat certain infections caused by bacteria.

These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride tablets may be used along with other treatments for severe acne. Sometimes, other germs, called viruses cause infections.

The common cold is a virus. Minocycline hydrochloride tablets, like other antibiotics, does not treat viruses. Who should not use m inocycline hydrochloride tablets ?

Do not take m inocycline hydrochloride tablets if you are allergic to minocycline or other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medications if you are not sure. See the end of this leaflet for a complete list of ingredients in minocycline hydrochloride tablets.

M inocycline hydrochloride tablets are not recommended for pregnant women or children up to 8 years old because: 1. Minocycline hydrochloride tablets may harm an unborn baby. 2.

Minocycline hydrochloride tablets may permanently turn a baby’s or child’s teeth yellow-gray-brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years. What should I tell my doctor before starting minocycline hydrochloride tablets ?

Tell your doctor about all of your medical conditions, including if you: have liver or kidney problems. are pregnant or planning to become pregnant. Minocycline hydrochloride tablets may harm your unborn baby. Stop taking m inocycline hydrochloride tablets and call your doctor if you become pregnant while taking it. are breast feeding.

Minocycline hydrochloride passes into your milk and may harm your baby. You should decide whether to use minocycline hydrochloride tablets or breastfeed, but not both. Tell your doctor about all the medicines you are taking including prescription and non- prescription medications, vitamins, and herbal supplements.

Minocycline hydrochloride tablets and other medicines may interact. Especially tell your doctor if you take: birth control pills. Minocycline hydrochloride tablets may make your birth control pills less effective. a blood thinner medicine.

The dose of your blood thinner may have to be lowered. a penicillin antibiotic medicine. Minocycline hydrochloride tablets and penicillins should not be used together. Migraine medicines called ergot alkaloids.

An acne medicine called isotretinoin (Accutane ® , Amnesteem ® , Claravis ® , Sotret ® ). Antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.

How should I take m inocycline hydrochloride tablets? Take m inocycline hydrochloride tablets exactly as your doctor tells you to take them. Skipping doses or not taking all your minocycline hydrochloride tablets may: Decrease the effectiveness of the treatment.

Increase the chance that bacteria will develop resistance to minocycline hydrochloride. Take m inocycline hydrochloride tablets with a full glass of liquid. Taking minocycline hydrochloride tablets with enough liquid may lower your chance of getting irritation or ulcers in your esophagus.

Your esophagus is the tube that connects your mouth to your stomach. Minocycline hydrochloride tablets may be taken with or without food. If you forget to take minocycline hydrochloride tablets, take it as soon a…

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