minocycline hydrochloride 100 mg Capsule, 500-count
by Alvogen, Inc. · 500 CAPSULE in 1 BOTTLE (47781-546-05)
NDC 47781-0546-05
🏷️ FDA NDC (as labeled)
47781-546-05
billing pads the product segment with a zero
This package
Also comes in:
50 capsules 47781-0546-50
Rx only
Generic
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for 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 ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Nov 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
47781-546-05
Product NDC
47781-546
11-digit billing NDC
47781054605
NCPDP billing unit
EA — each (per item)
Application #
ANDA063067
Chemical class
Tetracycline-class Drug [EPC], Tetracyclines
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Nov 2023)
Route
ORAL
Dosage form
CAPSULE
Substance
MINOCYCLINE HYDROCHLORIDE
GCN Seq No
009226
GCN
40410
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 100 MG CAPSULE
FDB brand name
Minocycline Hcl
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 47781-546-05 — 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 → 47781-0546-05. 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
LabelerAlvogen, Inc.
Application holderALVOGEN INC
FDA applicationANDA063067 (ANDA)
Labeler code47781
Product typeHuman Prescription Drug
Portfolio32 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 100 MG CAPSULE 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Minocycline Hydrochloride — tap one for details:
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.
BIOTIN
Insignificant Depletion
CALCIUM
Insignificant Depletion
FOLIC ACID
Insignificant Depletion
IRON
Insignificant Depletion
MAGNESIUM
Insignificant Depletion
+6 more
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.
💬 Questions about minocycline hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.355 | $177.55 / 500 capsules |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 4% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Minocycline Hydrochloride 100 mg 00591-5695-50 | Actavis | 50 capsules | $0.353 | AB | Availability likely | +0% |
| Minocycline Hydrochloride 100 mg 00904-6888-06 | Major | 50 capsules | $0.353 | AB | Availability likely | +0% |
| Minocycline Hydrochloride 100 mg 13668-0484-05 | Torrent | 500 capsules | $0.353 | AB | Availability likely | +0% |
| Minocycline Hydrochloride 100 mg 60687-0336-65 | American | 50 capsules | $0.353 | AB | Availability likely | +0% |
| Minocycline Hydrochloride 100 mg 65862-0211-05 | Aurobindo | 500 capsules | $0.353 | AB | Availability likely | +0% |
| Minocycline hydrochloride 100 mg 68382-0318-18 | Zydus | 50 capsules | $0.353 | AB | Availability likely | +0% |
| minocycline hydrochloride 100 mgthis 47781-0546-05 | Alvogen, | 500 capsules | $0.355 | — | Discontinued | — |
| Minocycline Hydrochloride 100 mg 43063-0736-14 | PD-Rx | 14 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 50090-2579-00 | A-S | 60 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 51655-0004-20 | Northwind | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 55289-0201-14 | PD-Rx | 14 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 57664-0853-13 | Sun | 500 capsules | — | — | Discontinued | — |
| Minocycline hydrochloride 100 mg 63187-0036-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 63187-0850-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 68071-2225-08 | NuCare | 28 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 68071-2866-06 | NuCare | 60 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 68788-7052-01 | Preferred | 14 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 70518-1336-01 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 70518-4565-00 | REMEDYREPACK | 28 capsules | — | AB | FDA listed | — |
| Minocycline hydrochloride 100 mg 70771-1428-07 | Zydus | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71205-0272-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71205-0511-30 | Proficient | 30 capsules | — | — | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71335-0046-00 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71335-1045-00 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71335-1123-00 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 72162-2574-02 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline hydrochloride 100 mg 80425-0314-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 80425-0390-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Minocycline hydrochloride 100 mg 82868-0017-60 | Northwind | 60 capsules | — | AB | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Minocycline Hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 30%
Female · 69%
Unknown · 2%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 47781-0546-05 You're viewing this | 500 CAPSULE in 1 BOTTLE (47781-546-05) | $0.3551 / ea | $177.56 | 2017-10-31 | Discontinued by firm |
| 47781-0546-50 | 50 CAPSULE in 1 BOTTLE (47781-546-50) | $0.3551 / ea | $17.76 | 2017-10-31 | Discontinued by firm |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.3551 NADAC).
Pack size FAQ
What quantity is in NDC 47781-0546-05?
NDC 47781-0546-05 is a 500-count package — 500 capsule in 1 bottle.
What is the difference between NDC 47781-0546-05 and NDC 47781-0546-50?
Both are minocycline hydrochloride 100 mg Capsule — the drug itself is identical. NDC 47781-0546-05 is the 500-count package, while NDC 47781-0546-50 is the 50 capsules package.
What NDC number is used to bill for this package of minocycline hydrochloride 100 mg Capsule?
Bill NDC 47781-0546-05 — the 11-digit billing format is 47781054605. 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
Finished prescription product
No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — 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
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 47781-546-05, 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: 47781-0546-05, written without dashes as 47781054605. 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 47781-0546-05, the first segment (47781) is the labeler code FDA assigned to Alvogen, Inc.; the middle segment (0546) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 capsules (47781-0546-50). 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?
Alvogen, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.