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Tetracaine Hydrochloride 5 mg/mL Solution — NDC 70069-0596-01 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 — NDC 70069-596-01 (Billing 70069-0596-01)

by Somerset Therapeutics, LLC · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Tetracaine Hydrochloride 5 mg/mL Solution from Somerset Therapeutics, LLC, marketed since Dec 2024 and currently FDA-listed; retail pharmacies pay about $4.33 per mL (NADAC). It is this product's only package size.

NDC 70069-0596-01
🏷️ FDA NDC (as labeled) 70069-596-01 billing pads the product segment with a zero
Rx only Generic 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

NDC database record

One package, one record: these facts belong to NDC 70069-596-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70069 labeler · 596 product · 01 package
Package marketed since
Dec 23, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0370069596012, 0370069597019
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70069-596-01
Product NDC 70069-596
11-digit billing NDC 70069059601
NCPDP billing unit ML — per mL (volume)
RxCUI 1547771
UNII 5NF5D4OPCI
UPC 0370069596012, 0370069597019
Application # ANDA217227
SPL Set ID bab63a18-3069-48a1-896e-433725f1dbaf
Established class (EPC) Ester Local Anesthetic
Physiologic effect Local Anesthesia
Chemical class Esters
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-23
Route OPHTHALMIC
Dosage form SOLUTION
Substance TETRACAINE HYDROCHLORIDE
TE code (Orange Book) AB1 · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86750030102005
GCN Seq No 007861
GCN 32881
HICL code 001482
Ingredient (HICL) Tetracaine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6H
Therapeutic class — specific (HIC3) Eye Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name TETRACAINE 0.5% EYE DROP
FDB brand name Tetracaine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007861
  • GCN: 32881
  • GPI-14 (Medi-Span): 86750030102005
  • HICL (First Databank): 001482
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 1547771
Why two NDCs? The FDA registers this code as 70069-596-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70069-0596-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

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

Label name TETRACAINE 0.5% EYE DROP Ingredient Tetracaine Hcl

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 $4.330 $21.65 / 5 ml
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 mL) — tap or hover for the price & month
Dec 2025 Apr 2026 Jun 2026 Sep 2026 $4.862 $3.993
▼ Down 11% over the last 8 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70069-0596-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2024-12-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tetracaine Hydrochloride 5 mg/mLthis 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/mL 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 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

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.

Manufacturer & labeler

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA217227 (ANDA)
Labeler code70069
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio184 products on file

More NDCs from Somerset Therapeutics, LLC labeler code 70069

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 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 43 words ▾

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

⏱️ Dosage and Administration 21 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 34 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. Ophthalmic solution containing 0.5% tetracaine hydrochloride. (3)

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. (4)

⚠️ Warnings and Cautions 216 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) For Administration by Healthcare Provider : Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is not intended for patient self- administration. (5.4)

5.1Corneal Injury with Intracameral Use Not for injection or intraocular use. Do not use intracamerally because use of tetracaine hydrochloride ophthalmic solution, 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.

5.4For Administration by Healthcare Provider Tetracaine hydrochloride ophthalmic solution, 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution, 0.5% is not intended for patient self-administration [see Warnings and Precautions (5.2)] .

🤒 Adverse Reactions 140 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, 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 Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations 201 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution, 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, 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, 0.5% and any potential adverse effects on the breastfed child from tetracaine hydrochloride ophthalmic solution, 0.5%.

8.3Females and Males of Reproductive Potential No human data on the effect of tetracaine hydrochloride ophthalmic solution, 0.5% on fertility are available.

8.4Pediatric Use Safety of tetracaine hydrochloride ophthalmic solution, 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution, 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, 0.5% have been observed between elderly and younger patients.

🤰 Pregnancy 37 words ▾

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

🧒 Pediatric Use 46 words ▾

8.4Pediatric Use Safety of tetracaine hydrochloride ophthalmic solution, 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution, 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

🧓 Geriatric Use 24 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution, 0.5% have been observed between elderly and younger patients.

🆘 Overdosage 26 words ▾

10 OVERDOSAGE Prolonged use of a topical ocular anesthetic including tetracaine hydrochloride ophthalmic solution, 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.

🧬 Clinical Pharmacology 59 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, 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 95 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 white LDPE bottle, plugged with white LDPE nozzle and capped with white HDPE cap in the following sizes: NDC 70069-596-01, 5 mL fill in 5 mL Bottle NDC 70069-597-01, 15 mL fill in 15 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 117 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 C 15 H 24 N 2 O 2 ● HCl and it is represented by the chemical structure: Tetracaine hydrochloride is a white crystalline 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). Image

💬 Information for Patients 52 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.

🧬 Pharmacokinetics 34 words ▾

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

🔬 Clinical Studies 51 words ▾

14 CLINICAL STUDIES Topical administration of tetracaine hydrochloride ophthalmic solution, 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.

📄 Recent Major Changes 8 words ▾

RECENT MAJOR CHANGES Warnings and Precautions (5.4) 2/2022

📄 Package Label / Principal Display Panel 68 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 5 mL Carton Label NDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 5 mL Container Label NDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mL Carton Label NDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mL Image Image Image Image

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.
← 70069-0591-10 · Somerset 70069-0597-01 · Somerset →
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.