Home › NDC Lookup › Ingredients › Tetracaine Hydrochloride › 00187-0920-05
Tetracaine Hydrochloride 5 mg/mL Solution/ Drops — NDC 00187-0920-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tetracaine Hydrochloride 5 mg/mL Solution/ Drops — NDC 0187-0920-05 (Billing 00187-0920-05)

by Bausch Health US LLC · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Tetracaine Hydrochloride 5 mg/mL Solution/ Drops from Bausch Health US LLC, marketed since Jun 2019 and currently FDA-listed, this package's marketing is listed to end Apr 2027. It is this product's only package size.

NDC 00187-0920-05
🏷️ FDA NDC (as labeled) 0187-0920-05 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0187-0920-05
Product NDC 0187-0920
11-digit billing NDC 00187092005
RxCUI 1547771
UNII 5NF5D4OPCI
Application # NDA210821
SPL Set ID 78404c9e-9c31-4b0a-90f4-04182e82e183
Established class (EPC) Ester Local Anesthetic
Physiologic effect Local Anesthesia
Chemical class Esters
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-27
Marketing end 2027-04-30
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance TETRACAINE HYDROCHLORIDE
TE code (Orange Book) AB1 · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1547771
Why two NDCs? The FDA registers this code as 0187-0920-05 — a 4-4-2 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 labeler segment → 00187-0920-05. 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.

RxNorm drug class

This medicine belongs to the Ester Local Anesthetic class.

Pharmacologic class Ester Local Anesthetic
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

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.

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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00187-0920-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2020-04-05 Apr 30, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tetracaine Hydrochloride 5 mg/mL 70069-0596-01 Somerset 1 bottle $4.330 AB1 Availability likely —
Tetracaine Hydrochloride 5 mg/mL 82260-0920-05 Bausch 1 bottle $4.330 AB1 Availability likely —
Tetracaine Hydrochloride 5 mg/mL 00065-0741-14 Alcon 1 bottle — — FDA listed —
Tetracaine Hydrochloride 5 mg/mLthis 00187-0920-05 Bausch 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 24208-0092-05 Bausch 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 50090-2364-01 A-S 4 ml — — FDA listed —
Tetracaine Hydrochloride 5 mg/mL 68682-0920-05 Oceanside 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 70069-0597-01 Somerset 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 70518-4183-00 REMEDYREPACK 12 bottles — — FDA listed —
Tetracaine Hydrochloride 5 mg/mL 85766-0229-05 Sportpharm 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 85766-0230-15 Sportpharm 1 bottle — AB1 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

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

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

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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 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.

Manufacturer & labeler

LabelerBausch Health US LLC
Application holderBAUSCH AND LOMB IRELAND LTD
FDA applicationNDA210821 (NDA)
Labeler code00187
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio41 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 47 words ▾

1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )

⏱️ Dosage and Administration 23 words ▾

2 DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. One drop topically in the eye(s) as needed. ( 2 )

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a clear, colorless, ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v. Sterile, preserved, ophthalmic solution containing 0.5% tetracaine hydrochloride. ( 3 )

⛔ Contraindications 51 words ▾

4 CONTRAINDICATIONS Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, should not be used in patients with a history of hypersensitivity to any component of this preparation. ( 4 )

⚠️ Warnings and Cautions 163 words ▾

5 WARNINGS AND PRECAUTIONS Do not use intracamerally since use may damage corneal endothelial cells. ( 5.1 ) Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. ( 5.2 ) Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.3 )

5.1Corneal Injury with Intracameral Use Not for injection or intraocular use. Do not use intracamerally because use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may lead to damage of the corneal endothelial cells.

5.2Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.

5.3Corneal Injury due to Insensitivity Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.

🤒 Adverse Reactions 144 words ▾

6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal Injury with Intracameral Use [See Warnings and Precautions ( 5.1 )] Corneal Toxicity [See Warnings and Precautions ( 5.2 )] Corneal Injury due to Insensitivity [See Warnings and Precautions ( 5.3 )] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%. 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.

Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations 209 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

8.2Lactation Risk Summary There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is excreted in human milk or to assess its effects on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%.

8.3Females and Males of Reproductive Potential No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% on fertility are available.

8.4Pediatric Use Safety of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

8.5Geriatric Use No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% have been observed between elderly and younger patients.

🤰 Pregnancy 38 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

🧒 Pediatric Use 48 words ▾

8.4Pediatric Use Safety of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

🧓 Geriatric Use 25 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% have been observed between elderly and younger patients.

🆘 Overdosage 27 words ▾

10 OVERDOSAGE Prolonged use of a topical ocular anesthetic including Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.

🧬 Clinical Pharmacology 60 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

12.3Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

📦 How Supplied / Storage and Handling 88 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a low-density polyethylene plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap in the following sizes: NDC 0187-920-05 5 mL in a 7.5 mL Bottle After opening, this product can be used until the expiration date stamped on the bottle. Storage : Store at 15° to 25°C (59° to 77°F). Protect from light.

Do not use if solution contains crystals, cloudy, or discolored.

📋 Description 115 words ▾

11 DESCRIPTION Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a sterile, clear, colorless, topical local anesthetic for ophthalmic use only containing tetracaine hydrochloride as the active pharmaceutical ingredient. Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-, 2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C15H24N2O2 • HCl and it is represented by the chemical structure: Tetracaine hydrochloride is a fine, white, crystalline, odorless powder with a molecular weight of 300.82 Active ingredient : tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine) Preservative : chlorobutanol 0.4% Inactive ingredients : boric acid, potassium chloride, edetate disodium dihydrate, water for injection.

Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0). chemstructure.jpg

💬 Information for Patients 85 words ▾

17 PATIENT COUNSELING INFORMATION Eye Care Precaution Do not touch the dropper tip to any surface as this may contaminate the solution. Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive for up to 20 minutes and that care should be taken to avoid accidental injuries. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2020 Bausch Health Companies Inc. or its affiliates 9xxxxxx (Folded) 9xxxxxx (Flat)

🧬 Pharmacokinetics 35 words ▾

12.3Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

🔬 Clinical Studies 53 words ▾

14 CLINICAL STUDIES Topical administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% results in localized temporary anesthesia. The maximum effect is achieved within 10–20 seconds after instillation, with efficacy lasting 10–20 minutes. Duration of effect can be extended with repeated dosing. [See Warnings and Precautions ( 5.2 ) and Overdosage ( 10 )].

🧪 Nonclinical Toxicology 59 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 56 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

📄 Package Label / Principal Display Panel 31 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Carton 5 mL NDC 0187-0920-05 Rx only Tetracaine Hydrochloride Ophthalmic Solution, USP 0.05% (Sterile) 5 mL BAUSCH Health C:\Users\dale.iannetti\OneDrive - Valeant Pharmaceuticals North America, LLC\Documents\SPL Assignments\2020\Tetracaine B&L\carton.jpg

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

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 Tetracaine hydrochloride — the ingredient across all brands.

Top reported reactions

Toxic Anterior Segment Syndrome27
Nausea15
Syncope15
Aqueous Fibrin14
Inflammation14
Abdominal Discomfort12
Oropharyngeal Pain12

Age at onset

Neonate1
Adult6
Elderly14

Reporter sex

156 reports
Male · 32%
Female · 68%

Serious outcomes

Life-threatening20
Death19
Disabling10
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Bausch Health US LLC has reported a marketing end date of 2027-04-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bausch Health US LLC 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.
← 00187-0799-42 · Bausch 00187-0938-01 · Bausch →
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.