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Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release, 1,000-count

by Aurobindo Pharma Limited · 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-99)

NDC 65862-0885-99

🏷️ FDA NDC (as labeled) 65862-885-99 billing pads the product segment with a zero

This package

Contains1,000-count Pack sizes4 compare ↓

Also priced by: Part D plans $22.27/unit — full pricing hub ↓

Also comes in: 30 tablets 65862-0885-30 100 tablets 65862-0885-01 500 tablets 65862-0885-05

Rx only Generic On market Non-controlled

🗂️ Data synced 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 Dr. Brian Staiger, PharmD

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) 65862-885-99

Product NDC 65862-885

11-digit billing NDC 65862088599

RxCUI 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665

UNII 0020414E5U

UPC 0365862555304

Application # ANDA202261

SPL Set ID e7b88a48-12b3-461d-b356-0d7ae4e8fd44

Established class (EPC) Tetracycline-class Drug

Physiologic effect Decreased Prothrombin Activity

Chemical class Tetracyclines

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-06-13

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance MINOCYCLINE HYDROCHLORIDE

GPI-14 04000040107533

GPI class Minocycline HCl ER

GCN Seq No 066685

GCN 29045

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 ER 105 MG TABLET

FDB brand name Minocycline Hcl Er

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 65862-885-99 — 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 → 65862-0885-99. 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, Antiinfectives for treatment of acne, 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.

🏭 Manufacturer & labeler

LabelerAurobindo Pharma Limited

Application holderAUROBINDO PHARMA LTD

FDA applicationANDA202261 (ANDA)

Labeler code65862

First marketedJun 2016

Product typeHuman Prescription Drug

Portfolio1,452 products on file

🔎 All NDCs from Aurobindo Pharma Limited

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 ER 105 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Minocycline Hydrochloride — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Minocycline Hydrochloride (161 interactions) — ranked by severity →

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.

BIOTIN Insignificant Depletion CALCIUM Insignificant Depletion FOLIC ACID Insignificant Depletion IRON Insignificant Depletion MAGNESIUM Insignificant Depletion +6 more

🧪 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 Gray / Pink / Blue / Yellow / Purple / Green / Red

ShapeCapsule

ImprintI;93

Size16 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 2LRS185U6K
D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII 39J80LT57T
Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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 G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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 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.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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 system	Per each	Per 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	$22.27	$22,270.00 / 1000 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Minocycline Hydrochloride 105 mg 63629-9208-01	Bryant	30 tablets	—	AB	FDA listed	—
Minocycline Hydrochloride 105 mgthis 65862-0885-99	Aurobindo	1000 tablets	—	AB	FDA listed	—
Minocycline Hydrochloride 105 mg 67877-0438-01	Ascend	100 tablets	—	AB	FDA listed	—
minocycline hydrochloride 105 mg 68382-0552-01	Zydus	100 tablets	—	—	FDA listed	—
minocycline hydrochloride 105 mg 70771-1157-00	Zydus	1000 tablets	—	—	FDA listed	—
Minocycline Hydrochloride 105 mg 71335-2904-01	Bryant	30 tablets	—	AB	FDA listed	—
Minocycline Hydrochloride 105 mg 72162-1840-03	Bryant	30 tablets	—	AB	FDA listed	—
Minocycline Hydrochloride 105 mg 72789-0528-30	PD-Rx	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2016

On the market since

Jun 2016

📍

2026

Currently FDA-listed

10 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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

Where does this data come from?

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

🔬 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

Male · 30%

Female · 69%

Unknown · 2%

Serious outcomes

Life-threatening1,430

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
65862-0885-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-01)	2016-06-13	Active
65862-0885-05	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-05)	2016-06-13	Active
65862-0885-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-30)	2016-06-13	Active
65862-0885-99 You're viewing this	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-99)	2016-06-13	Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65862-0885-99?

NDC 65862-0885-99 is a 1,000-count package — 1000 tablet, film coated, extended release in 1 bottle.

What is the difference between NDC 65862-0885-99 and NDC 65862-0885-30?

Both are Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 65862-0885-99 is the 1,000-count package, while NDC 65862-0885-30 is the 30 tablets package.

What NDC number is used to bill for this package of Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release?

Bill NDC 65862-0885-99 — the 11-digit billing format is 65862088599. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

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)	— 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 FDA registers it as 65862-885-99, 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: 65862-0885-99, written without dashes as 65862088599. 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 65862-0885-99, the first segment (65862) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0885) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) 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 3 other package presentations of this same product, including 30 tablets (65862-0885-30), 100 tablets (65862-0885-01), 500 tablets (65862-0885-05). 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.

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.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 168 words ▾

1 INDICATIONS AND USAGE Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14) ].

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12) ] . Minocycline hydrochloride is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections.

To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated. ( 1 )

⏱️ Dosage and Administration 204 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. Table 1 provides the recommended minocycline hydrochloride extended-release tablets dosage based upon weight ranges. Table 1: Dosing Table for Minocycline Hydrochloride Extended-Release Tablets Patient’s Weight (kg) Recommended Dosage (mg/day) 45 to 49 45 50 to 59 55 60 to 71 65 72 to 84 80 85 to 96 90 97 to 110 105 111 to 125 115 126 to 136 135 Higher dosages have not shown to be of additional benefit in the treatment of inflammatory lesions of acne and may be associated with more acute vestibular adverse reactions.

Swallow tablets whole. Do not chew, crush, or split the extended-release tablets. Administer minocycline hydrochloride extended-release tablets with or without food [see Clinical Pharmacology (12.3) ] .

Ingestion of food along with minocycline hydrochloride extended-release tablets may help reduce the risk of esophageal irritation and ulceration. In patients with renal impairment, decrease the daily dosage by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.9) ]. The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks.

(2)

💊 Dosage Forms and Strengths 214 words ▾

3 DOSAGE FORMS AND STRENGTHS 45 mg extended-release tablets: Gray colored, round shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘95’ on the other side. 55 mg extended-release tablets: Pink colored, round shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘6’ on the other side. 65 mg extended-release tablets: Blue colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘26’ on the other side.

80 mg extended-release tablets: Grey colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘7’ on the other side. 90 mg extended-release tablets: Yellow colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘27’ on the other side. 105 mg extended-release tablets: Purple colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘8’ on the other side.

115 mg extended-release tablets: Green colored, capsule shaped, biconvex, film-coated tablets debossed with ‘F81’ on one side and plain on the other side. 135 mg extended-release tablets: Red colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘93’ on the other side. Extended-release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg (3)

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS Minocycline hydrochloride extended-release tablets are contraindicated in patients with history of a hypersensitivity reaction to any of the tetracyclines [see Warnings and Precautions (5.1) ] . Known hypersensitivity to any of the tetracyclines. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Skin/Hypersensitivity Reactions : Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue immediately if symptoms occur. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown).

( 5.2 , 8.1 , 8.4 ) Inhibition of Bone Growth: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.3 , 8.1 , 8.4 ) Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis): Discontinue if Clostridioides difficile -associated diarrhea (antibiotic-associated colitis) occurs. ( 5.4 ) Hepatotoxicity : Discontinue if liver injury is suspected.

( 5.5 ) Central Nervous System Effects: May cause central nervous system side effects including light-headedness, dizziness, or vertigo. ( 5.6 ) Idiopathic Intracranial Hypertension: May cause idiopathic intracranial hypertension in adults and adolescents. Discontinue if symptoms occur.

( 5.7 ) Autoimmune Syndromes : Minocycline has been associated with autoimmune syndromes; discontinue immediately if symptoms occur. ( 5.8 ) Metabolic Effects : If renal impairment exists, reduce minocycline hydrochloride extended-release tablets dosage. ( 5.9 )

5.1Serious Skin/Hypersensitivity Reactions Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis.

Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, minocycline hydrochloride extended-release tablets should be discontinued immediately.

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 (6.2) ] . If severe skin/hypersensitivity reactions occur, discontinue minocycline hydrochloride extended-release tablets and institute appropriate therapy.

5.2Tooth Discoloration and Enamel Hypoplasia The use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-graybrown). Permanent discoloration of the teeth is more common during long-term use of tetracycline-class drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Use of minocycline hydrochloride extended-release tablets are not recommended during tooth development. Advise the patient of the potential risk to the fetus if minocycline hydrochloride extended-release tablets are used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ].

5.3Inhibition of Bone Growth The use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including minocycline hydrochloride extended-release tablets, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants giv…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Skin/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Central Nervous System Effects [see Warnings and Precautions (5.6) ] Idiopathic Intracranial Hypertension [see Warnings and Precautions (5.7) ] The most commonly observed adverse reactions (incidence ≥5%) are headache, fatigue, dizziness, and pruritus.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended-release tablets and higher than placebo. Table 2: Selected Treatment-Emergent Adverse Reactions in at Least 1% of Clinical Trial Subjects and Higher than Placebo Adverse Reactions Minocycline Hydrochloride Extended-Release Tablets (1 mg/kg) N = 674 (%) Placebo N = 364 (%) At least one treatment-emergent event 379 (56) 197 (54) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1)

6.2Postmarketing Experience The following adverse reactions have been reported with minocycline hydrochloride use in a variety of indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and hypersensitivity reactions: anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet’s syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome. Central nervous system: idiopathic intracranial hypertension, bulging fontanels in infants, decreased hearing. Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function.

Oncology: thyroid cancer. Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

🔄 Drug Interactions 108 words ▾

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 )

7.1Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2Penicillin Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving minocycline hydrochloride extended-release tablets in conjunction with penicillin.

7.3Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium and iron-containing preparations.

7.4Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Tetracycline class drugs, including minocycline hydrochloride extended-release tablets may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.2 , 5.3) and Use in Specific Populations (8.4)]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, fetuses with bent limb bones were observed following oral administration of minocycline during organogenesis at systemic exposures 3 and 2 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) (see Data) . If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and to discontinue treatment. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data The use of tetracycline class drugs, including minocycline hydrochloride extended-release tablets, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown).

Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions (5.2) ] . Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions (5.3) ].

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively (3 times the MRHD and 2 times the MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC comparison basis). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at dosages of 5, 10, or 50 mg/kg/day.

In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities.

No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline.

8.2Lactation Risk Summary Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not r…

🤰 Pregnancy ~2 min read ▾

No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline.

🧒 Pediatric Use 112 words ▾

8.4Pediatric Use The safety and effectiveness of minocycline hydrochloride extended-release tablets have been established in pediatric patients 12 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris [see Clinical Studies (14) ] . Tooth discoloration and inhibition of bone growth have been observed in pediatric patients [see Warnings and Precaution (5.2 , 5.3) ] . Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions (5.2) ] .

Safety and effectiveness of minocycline hydrochloride extended-release tablets have not been established in pediatric patients younger than 12 years of age.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Clinical studies of minocycline hydrochloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 concomitant disease or other drug therapy.

🆘 Overdosage 39 words ▾

10 OVERDOSAGE Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue minocycline hydrochloride extended-release tablets, treat symptomatically, and institute supportive measures. Call Poison Control Center at 1-800-222-1222 for the latest recommendations.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.

12.2Pharmacodynamics The pharmacodynamics of minocycline hydrochloride extended-release tablets for the treatment of acne are unknown.

12.3Pharmacokinetics Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, minocycline hydrochloride extended-release tablets produce a delayed T max at 3.5 to 4 hours as compared to a non-modified release reference minocycline product (T max at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC (0–24) and C max were 33.32 mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended-release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules, respectively.

These parameters are based on dose adjusted to 135 mg/day for both products. A single-dose, four-way crossover study demonstrated that minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, minocycline hydrochloride extended-release tablets 55 mg, 80 mg, and 105 mg were shown to be dose-proportional to minocycline hydrochloride extended-release tablets 90 mg and 135 mg.

When minocycline hydrochloride extended-release tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions. Minocycline is lipid soluble and distributes into the skin and sebum. 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.

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Minocycline Hydrochloride Extended-Release Tablets USP, 45 mg are gray colored, round shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘95’ on the other side. Bottles of 30 NDC 65862-554-30 Bottles of 100 NDC 65862-554-01 Bottles of 1,000 NDC 65862-554-99 Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg are pink colored, round shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘6’ on the other side. Bottles of 30 NDC 65862-883-30 Bottles of 100 NDC 65862-883-01 Bottles of 500 NDC 65862-883-05 Bottles of 1,000 NDC 65862-883-99 Minocycline Hydrochloride Extended-Release Tablets USP, 65 mg are blue colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘26’ on the other side.

Bottles of 30 NDC 65862-555-30 Bottles of 1,000 NDC 65862-555-99 Minocycline Hydrochloride Extended-Release Tablets USP, 80 mg are grey colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘7’ on the other side. Bottles of 30 NDC 65862-884-30 Bottles of 100 NDC 65862-884-01 Bottles of 500 NDC 65862-884-05 Bottles of 1,000 NDC 65862-884-99 Minocycline Hydrochloride Extended-Release Tablets USP, 90 mg are yellow colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘27’ on the other side.

Bottles of 30 NDC 65862-556-30 Bottles of 100 NDC 65862-556-01 Bottles of 1,000 NDC 65862-556-99 Minocycline Hydrochloride Extended-Release Tablets USP, 105 mg are purple colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘8’ on the other side. Bottles of 30 NDC 65862-885-30 Bottles of 100 NDC 65862-885-01 Bottles of 500 NDC 65862-885-05 Bottles of 1,000 NDC 65862-885-99 Minocycline Hydrochloride Extended-Release Tablets USP, 115 mg are green colored, capsule shaped, biconvex, film-coated tablets debossed with ‘F81’ on one side and plain on the other side.

Bottles of 30 NDC 65862-557-30 Bottles of 1,000 NDC 65862-557-99 Minocycline Hydrochloride Extended-Release Tablets USP, 135 mg are red colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘93’ on the other side. Bottles of 30 NDC 65862-558-30 Bottles of 100 NDC 65862-558-01 Bottles of 1,000 NDC 65862-558-99 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Handling Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure.

📋 Description ~1 min read ▾

11 DESCRIPTION Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below: Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin.

The 45 mg extended-release tablets also contain iron oxide black. The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol.

The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol.

The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. Meets USP dissolution test 2 for 45 mg, 90 mg and 135 mg.

FDA approved dissolution test specifications differ from USP for 55 mg, 65 mg, 80 mg, 105 mg and 115 mg. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Patients taking minocycline hydrochloride extended-release tablets should receive the following information and instructions: Administration Instructions Minocycline hydrochloride extended-release tablets should be taken exactly as directed. Advise patients to swallow minocycline hydrochloride extended-release tablets whole and not to chew, crush, or split the tablets [see Dosage and Administration (2) ] .

Serious Skin/Hypersensitivity Reactions Inform patients that serious skin reactions have occurred with the minocycline use in patients with acne. Advise patients to discontinue use of minocycline hydrochloride extended-release tablets and contact their healthcare provider immediately at the first evidence of skin erythema [see Warnings and Precautions (5.1) ] . Tooth Discoloration and Enamel Hypoplasia Advise patients that minocycline hydrochloride extended-release tablets use in pregnancy may cause permanent tooth discoloration of deciduous teeth.

Advise patients to discontinue minocycline hydrochloride extended-release tablets during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1) ] . Advise caregivers of pediatric patients that minocycline hydrochloride extended-release tablets use may cause permanent discoloration of deciduous and permanent teeth [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . Inhibition of Bone Growth Advise patients that minocycline hydrochloride extended-release tablets use in pregnancy may cause inhibition of fetal bone growth.

Advise patients to discontinue minocycline hydrochloride extended-release tablets during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.3) , Use in Specific Populations (8.1) ]. Clostridioides difficile- Associated Diarrhea (Antibiotic-Associated Colitis) Advise patients that Clostridioides difficile- associated diarrhea (antibiotic-associated colitis) can occur with minocycline therapy, including minocycline hydrochloride extended-release tablets.

If patients develop watery or bloody stools, advise patients to seek medical attention [see Warnings and Precautions (5.4) ] . Hepatotoxicity Inform patients about the possibility of hepatotoxicity. Advise patients to seek medical advice if they experience signs or symptoms of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, bleeding easily, confusion, and sleepiness [see Warnings and Precautions (5.5) ] .

Central Nervous System Effects Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on minocycline hydrochloride extended-release tablets [see Warnings and Precautions (5.6) ] . Idiopathic Intracranial Hypertension Inform patients that idiopathic intracranial hypertension can occur with minocycline therapy.

Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss [see Warnings and Precautions (5.7) ] . Autoimmune Syndromes Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis, and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash, and malaise.

Advise patients who experience such symptoms to immediately discontinue minocycline hydrochloride extended-release tablets and seek medical help [see Warnings and Precautions (5.8) ] . Photosensitivity Inform patients that photosensitivity manifested by an exaggerated sunburn r…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

lupus-like syndrome: A set of symptoms resembling lupus, such as joint pain, rash, and fever, that appears while taking a substance and usually settles after stopping it.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

arthralgia: Joint pain.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

autoimmune: Describes a condition in which the body's defense system mistakenly attacks its own healthy cells or tissues.

bactericidal: Describes a medicine that kills bacteria outright.

bacteriostatic: Describes a medicine that stops bacteria from multiplying so the body's own defenses can clear them.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diplopia: Double vision, or seeing two images of a single object.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

DRESS syndrome: A rare, serious reaction with rash, fever, swollen glands, and inflammation of internal organs, sometimes appearing weeks after starting a medicine.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysphagia: Trouble or discomfort swallowing food, liquids, or pills.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

febrile: Having a fever, or relating to a fever.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

pruritus: Itching of the skin.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

susceptibility testing: A lab test that grows germs from a sample and checks which medicines can stop or kill them.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 65862-0884-01 · Aurobindo 65862-0886-88 · Aurobindo →

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.

Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release, 1,000-count

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