NDC 68083-0649-02 — Alcaftadine 2.5 mg/mL Solution/ Drops

🆔 Identity & classification

FDA NDC (as labeled) 68083-649-02

Product NDC 68083-649

11-digit billing NDC 68083064902

RxCUI 1000085

UNII 7Z8O94ECSX

Application # ANDA209706

SPL Set ID b94e071d-421d-48ec-a4ea-254aa8af19ff

Established class (EPC) Histamine-1 Receptor Antagonist

Mechanism of action Histamine H1 Receptor Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-03-01

Route OPHTHALMIC

Dosage form SOLUTION/ DROPS

Substance ALCAFTADINE

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 ALCAFTADINE 0.25% EYE DROP

FDB brand name Alcaftadine

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

Why two NDCs? The FDA registers this code as 68083-649-02 — 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 → 68083-0649-02. 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

LabelerGland Pharma Limited

Application holderGLAND PHARMA LTD

FDA applicationANDA209706 (ANDA)

Labeler code68083

First marketedMar 2024

Product typeHuman Otc Drug

Portfolio262 products on file

🔎 All NDCs from Gland Pharma Limited

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 ALCAFTADINE 0.25% EYE DROP 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, sodium chloride, sodium hydroxide and/or hydrochloric acid, water for injection

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	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.

Try another pack size: 3 mL

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/mL 00023-4290-01	Allergan,	1 bottle	—	—	FDA listed	—
Lastacaft 2.5 mg/mL 00023-4291-01	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/mLthis 68083-0649-02	Gland	2 bottles	—	—	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

Mar 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.

🔬 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 Alcaftadine — the ingredient across all brands.

Top reported reactions

Ocular Hyperaemia298

Eye Irritation170

Eye Pain103

Eye Pruritus102

Eye Swelling83

Hypersensitivity63

Lacrimation Increased57

Age at onset

Child2

Adolescent1

Adult24

Elderly16

Reporter sex

Male · 21%

Female · 79%

Serious outcomes

Hospitalization37

Disabling7

Death5

Life-threatening4

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
68083-0649-01	1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE	2024-03-01	Active
68083-0649-02 You're viewing this	2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE	2024-03-01	Active

Pack size FAQ

What quantity is in NDC 68083-0649-02?

NDC 68083-0649-02 is listed by the FDA — 2 bottle in 1 carton / 3 ml in 1 bottle.

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

Bill NDC 68083-0649-02 — the 11-digit billing format is 68083064902. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no 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 FDA registers it as 68083-649-02, 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: 68083-0649-02, written without dashes as 68083064902. 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 68083-0649-02, the first segment (68083) is the labeler code FDA assigned to Gland Pharma Limited; the middle segment (0649) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Gland Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (68083-0649-01). 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?

Gland Pharma Limited 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

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.

📄 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 14 words ▾

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

⏱️ Dosage and Administration 50 words ▾

Directions adults 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 children under 2 years of age: consult a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 4 words ▾

Active ingredient Alcaftadine 0.25%

🧪 Inactive Ingredients 20 words ▾

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

🎯 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 Gland labeler NDCsLabeler code 68083 📚 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.