NDC 00023-4291-05 — LASTACAFT alcaftadine 2.5 mg/mL

🆔 Identity & classification

FDA NDC (as labeled) 0023-4291-05

Product NDC 0023-4291

11-digit billing NDC 00023429105

NCPDP billing unit ML — per mL (volume)

RxCUI 1000085, 1000089

UNII 7Z8O94ECSX

Application # NDA022134

SPL Set ID a3002410-4bf1-4182-9d7c-8193eb7cd215

Established class (EPC) Histamine-1 Receptor Antagonist

Mechanism of action Histamine H1 Receptor Antagonists

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-12-01

Route OPHTHALMIC

Dosage form SOLUTION/ DROPS

Substance ALCAFTADINE

GPI-14 86802004002020

GPI class Lastacaft

GCN Seq No 066954

GCN 29389

HICL code 037330

Ingredient (HICL) Alcaftadine

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 Q6R

Therapeutic class — specific (HIC3) Eye Antihistamines

AHFS code 04:08.00.00

AHFS class Second Generation Antihistamines

FDB label name LASTACAFT ONCE DAILY 0.25% DRP

FDB brand name Lastacaft Once Daily Relief

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 0023-4291-05 — 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 → 00023-4291-05. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist

Drug family (ATC) Other antiallergics

How it works Histamine H1 Receptor Antagonists

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

LabelerAllergan, Inc.

Application holderABBVIE INC

FDA applicationNDA022134 (NDA)

Labeler code00023

First marketedDec 2021

Product typeHuman Otc Drug

Portfolio188 products on file

🔎 All NDCs from Allergan, Inc.

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 LASTACAFT ONCE DAILY 0.25% DRP Ingredient Alcaftadine

📖 What it is MedlinePlus · NLM

Ophthalmic alcaftadine is used to relieve the itching of allergic pinkeye. Alcaftadine is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Lastacaft helps prevent the itching that comes with eye allergies (allergic conjunctivitis) — it's not a cure, but it can significantly reduce how much your eyes itch when allergen...
What exactly does Lastacaft do — will it stop my eye allergies completely?
No — you need to wait at least 10 minutes before reinserting your contacts. The preservative in Lastacaft can be soaked up by soft contact lenses, which isn't good for your eyes or...
Can I put my contact lenses back in right after using these drops?

📖 Read our full Alcaftadine Ophthalmic guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
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.

The official label also statesbenzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, purified water, sodium chloride, sodium hydroxide and/or hydrochloric acid

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 mL	Per package
Retail pharmacies payNADAC · weekly	$2.833	$14.17 / 5 ml
Medicaid paysCMS SDUD · 12 mo	$4.18	$20.88 / 5 ml
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

▲ Up 1% over the last 5 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
Lastacaft 2.5 mg/mLthis 00023-4291-05	Allergan,	1 bottle	$2.833	—	Availability likely	—
Lastacaft 2.5 mg/mL 00023-4290-01	Allergan,	1 bottle	—	—	FDA listed	—
Alcaftadine 2.5 mg/mL 58602-0605-40	Aurohealth	1 bottle	—	—	FDA listed	—
alcaftadine 2.5 mg/mL 62332-0147-03	Alembic	1 bottle	—	—	FDA listed	—
Alcaftadine 2.5 mg/mL 68083-0649-01	Gland	1 bottle	—	—	FDA listed	—

About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.

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

🏛️

2010

First FDA approval

Jul 2010

📍

2026

Currently FDA-listed

16 years listed

🛡️

2027

Latest patent/protection listed

not a guaranteed launch date

🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Jul 28, 2010 RLD RS ⏳ ~1.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 8664215 — method of use (U-3267)

US 10617695 — method of use (U-3267)

2010 2012 2014 2016 2018 2020 2022 2024 2026 2028

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)

Patent	Type	Use code	Expires
US 8664215 ↗	Method of use	U-3267	Dec 23, 2027
US 10617695 ↗	Method of use	U-3267	Mar 19, 2027

Common questions

Is there a generic version of LASTACAFT ONCE DAILY 0.25% DRP?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for LASTACAFT ONCE DAILY 0.25% DRP. See the alternatives section for substitutable, lower-cost products.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00023-4291-05, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

1.3K

Units reimbursed last 4 qtrs

6.5K

Gross reimbursed last 4 qtrs

$27K

Avg / prescription

$21.03

Avg / unit

$4.1754

Latest quarter Q4 2025

426Rx

Medicaid pays / mL

$4.1754

gross reimbursed

vs

NADAC / mL

$2.8333

acquisition cost

=

Spread

+$1.3421

+47% vs cost

What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

89% FFS

Fee-for-service · 1,147 Rx Managed care · 138 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.410.2

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 California 10.2 /100k

2 Colorado 7.4 /100k

3 New York 6.7 /100k

4 Ohio 4.3 /100k

5 South Carolina 1.2 /100k

6 Pennsylvania 0.5 /100k

7 Texas 0.4 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 bottle this page00023-4291-05 1,285 Rx · $27,023

2 bottles00023-4291-10 255 Rx · $7,470

1 bottle00023-4291-01 No Medicaid data

1 bottle00023-4291-06 No Medicaid data

2 bottles00023-4291-07 No Medicaid data

Drug total (last 4 qtrs): 1,540 Rx · 8,702 units · $34,494 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
00023-4291-01	1 BOTTLE, PLASTIC in 1 CARTON (0023-4291-01) / 1 mL in 1 BOTTLE, PLASTIC	—	—	2021-12-01	Active
00023-4291-05 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (0023-4291-05) / 5 mL in 1 BOTTLE, PLASTIC	$2.83 / mL	$14.17	2021-12-01	Active
00023-4291-06	1 BOTTLE, PLASTIC in 1 CARTON (0023-4291-06) / 5 mL in 1 BOTTLE, PLASTIC	—	—	2021-12-01	Active
00023-4291-07	2 BOTTLE, PLASTIC in 1 CARTON (0023-4291-07) / 5 mL in 1 BOTTLE, PLASTIC	—	—	2021-12-01	Active
00023-4291-10	2 BOTTLE, PLASTIC in 1 CARTON (0023-4291-10) / 5 mL in 1 BOTTLE, PLASTIC	—	—	2021-12-01	Active

In Medicaid, this is the most-dispensed pack of this product — about 83% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00023-4291-05?

NDC 00023-4291-05 is listed by the FDA — 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic.

What NDC number is used to bill for this package of LASTACAFT alcaftadine 2.5 mg/mL Solution/ Drops?

Bill NDC 00023-4291-05 — the 11-digit billing format is 00023429105. 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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 15 words ▾

Us e temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

⏱️ Dosage and Administration 53 words ▾

Directions a dults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use c hildren under 2 years of age : consult a doctor

⚠️ Warnings 137 words ▾

Warnings For external use only Do not use ■ if solution changes color or becomes cloudy ■ if you are sensitive to any ingredient in this product ■ to treat contact lens related irritation When using this product ■ do not touch tip of container to any surface to avoid contamination ■ remove contact lenses before use ■ wait at least 10 minutes before reinserting contact lenses after use ■ do not wear a contact lens if your eye is red Stop use and ask a doctor if you experience any of the following: ■ eye pain ■ changes in vision ■ increased redness of the eye ■ itching that worsens or lasts for more than 72 hours Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Active ingredient Alcaftadine 0.25%

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, purified water, sodium chloride, sodium hydroxide and/or hydrochloric acid

🎯 Purpose 2 words ▾

Purpose Antihistamine

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

🔗 Related NDC lookups

🧪 All Alcaftadine NDCsSame ingredient 🏭 All Allergan, labeler NDCsLabeler code 00023 📚 All Histamine-1 Receptor Antagonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Eye Antihistamines.

Olopatadine Hcl 00065-0816-01 Ketotifen Fumarate 00065-4011-05 Bepotastine Besilate 00378-7055-35 Azelastine Hcl 47335-0938-90 Epinastine Hcl 51991-0836-75 Cetirizine Hcl 71776-0024-30

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.