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💊no package photo
in the FDA label

Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 140; 125; 125 mg; mg; mg Capsule, 120-count

by Allergan, Inc. · 1 BLISTER PACK in 1 BOX (58914-601-20) / 120 CAPSULE in 1 BLISTER PACK
NDC 58914-0601-20
🏷️ FDA NDC (as labeled) 58914-601-20 billing pads the product segment with a zero
This package
Contains120-count Cost per ea$2.43 NADAC Per package$291.37 / 120 capsules Pack sizes2 compare ↓
Also comes in: 120 capsules 58914-0601-21
Rx only Brand 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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 May 2024. 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) 58914-601-20
Product NDC 58914-601
11-digit billing NDC 58914060120
NCPDP billing unit EA — each (per item)
Application # NDA050786
Chemical class Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2024)
Route ORAL
Dosage form CAPSULE
Substance BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
GCN Seq No 062462
GCN 98238
HICL code 020019
Ingredient (HICL) Bismuth/Metronid/Tetracycline
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4F
Therapeutic class — specific (HIC3) Anti-Ulcer-H.pylori Agents
AHFS code 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name PYLERA 140-125-125 MG CAPSULE
FDB brand name Pylera
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 58914-601-20 — 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 → 58914-0601-20. 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

LabelerAllergan, Inc.
Application holderLABORATOIRES JUVISE PHARMACEUTICALS
FDA applicationNDA050786 (NDA)
Labeler code58914
Product typeHuman Prescription Drug
Portfolio188 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 PYLERA 140-125-125 MG CAPSULE Ingredient Bismuth/Metronid/Tetracycline
📖 What it is MedlinePlus · NLM

Bismuth, metronidazole, and tetracycline is used to treat duodenal ulcers. It is in a class of medications called antibacterial agents. It works by preventing the growth and spread of Helicobacter pylori bacteria, which often occurs with ulcers. Treating this infection keeps ulcers from coming back.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You have an H. pylori infection, which is a stubborn stomach bacteria that's notoriously hard to kill. Using three ingredients together — two different antibiotics (metronidazole a...
  • What exactly is this medication doing — why do I need three drugs at once?
  • No — this is one of the most important rules with this medication. You need to avoid alcohol completely during the entire 10-day course AND for at least 3 days after your last dose...
  • This is actually expected and harmless with this medication. Bismuth subcitrate potassium — one of the three ingredients — temporarily darkens the tongue and turns stools black or...
📖 Read our full Bismuth, Metronidazole, and Tetracycline guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.428 $291.37 / 120 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
Dec 2021 Oct 2022 Nov 2023 $7.357 $2.428
▼ Down 67% over the last 3 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
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride 140 mg/1; 125 mg/1; 125 mg 49884-0151-54 Par 120 capsules $2.376 AB Availability likely save 2%
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 140 mg/1; 125 mg/1; 125 mg 50742-0283-13 Ingenus 120 capsules $2.376 AB Availability likely save 2%
Pylera 140 mg/1; 125 mg/1; 125 mg 61269-0380-12 H2-Pharma, 120 capsules $2.428 AB Availability likely +0%
Pylera 140 mg/1; 125 mg/1; 125 mg 61269-0381-12 H2-Pharma, 120 capsules $2.428 AB Availability likely +0%
Pylera 140; 125; 125 mg/1; mg/1; mgthis 58914-0601-20 Allergan, 120 capsules $2.428 AB Discontinued —
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride 140 mg/1; 125 mg/1; 125 mg 61269-0386-12 H2-Pharma, 120 capsules — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

Medicare Part D (outpatient prescription) spending for Pylera — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pylera. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$23.7K
Claims incl. refills
80
Beneficiaries
78
Spend / beneficiary
$304.40
Spend / claim
$296.79
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
58914-0601-20 You're viewing this 1 BLISTER PACK in 1 BOX (58914-601-20) / 120 CAPSULE in 1 BLISTER PACK $2.43 / ea $291.37 2013-08-01 Discontinued by firm
58914-0601-21 1 BOTTLE in 1 BOX (58914-601-21) / 120 CAPSULE in 1 BOTTLE — — 2013-08-01 Discontinued by firm

Pack size FAQ

What quantity is in NDC 58914-0601-20?
NDC 58914-0601-20 is a 120-count package — 1 blister pack in 1 box / 120 capsule in 1 blister pack.
What is the difference between NDC 58914-0601-20 and NDC 58914-0601-21?
Both are Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 140; 125; 125 mg; mg; mg Capsule — the drug itself is identical. NDC 58914-0601-20 is the 120-count package, while NDC 58914-0601-21 is the 120 capsules package.
What NDC number is used to bill for this package of Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 140; 125; 125 mg; mg; mg Capsule?
Bill NDC 58914-0601-20 — the 11-digit billing format is 58914060120. 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 The FDA label for this product carries no photos.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58914-601-20, 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: 58914-0601-20, written without dashes as 58914060120. 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 58914-0601-20, the first segment (58914) is the labeler code FDA assigned to Allergan, Inc.; the middle segment (0601) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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 120 capsules (58914-0601-21). 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?
Allergan, 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
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 58914-0501-33 · Allergan, 58914-0785-10 · Allergan, →
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.