Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Alcaftadine 2.5 mg/mL Solution/ Drops — NDC 68083-649-02 (Billing 68083-0649-02)
by Gland Pharma Limited · 2 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE
This is a package of Alcaftadine 2.5 mg/mL Solution/ Drops from Gland Pharma Limited, marketed since Mar 2024 and currently FDA-listed.
NDC 68083-0649-02
🏷️ FDA NDC (as labeled)
68083-649-02
billing pads the product segment with a zero
This package
Contains3 mL in 1 bottle
Pack sizes2 compare ↓
🗂️ FDA directory synced Oct 8, 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 →
NDC database record
One package, one record: these facts belong to NDC 68083-649-02 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 68083 labeler · 649 product · 02 package
- Package marketed since
- Mar 1, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6808364902 9
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
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
Quick answers
- GSN (GCN sequence number): 066954
- GCN: 29389
- HICL (First Databank): 037330
- AHFS class code: 04:08.00.00
- RxCUI (RxNorm): 1000085
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 itching in your eyes caused by eye allergies — specifically allergic conjunctivitis. It blocks the histamine receptors in your eyes and also stops allergy c...
- What exactly does Lastacaft do for my eyes?
- No — you need to wait at least 10 minutes after using Lastacaft before putting your lenses back in. That's because the preservative in the drops can be absorbed by soft contact len...
- Can I put my contact lenses back in right after using the drops?
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Alcaftadine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68083-0649-01 68083-649-01 Main listing | 1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE | 2024-03-01 | — | Active |
| 68083-0649-02 You're viewing this | 2 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE | 2024-03-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package 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?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Alcaftadine Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerGland Pharma Limited
Application holderGLAND PHARMA LTD
FDA applicationANDA209706 (ANDA)
Labeler code68083
First marketedMar 2024
Product typeHuman Otc Drug
Portfolio264 products on file
More NDCs from Gland Pharma Limited labeler code 68083
- ENOXAPARIN SODIUM 100 mg/mL Injection NDC 68083-638-10
- ENOXAPARIN SODIUM 120 mg/.8mL Injection NDC 68083-639-10
- ENOXAPARIN SODIUM 150 mg/mL Injection NDC 68083-640-10
- Epoprostenol 1.5 mg/10mL Injection, Powder, Lyophilized, For Solution NDC 68083-642-01
- Acetaminophen 10 mg/mL Injection, Solution NDC 68083-647-01
- Acetaminophen 10 mg/mL Injection, Solution NDC 68083-648-01
- Bortezomib 1 mg Injection, Powder, Lyophilized, For Solution NDC 68083-650-01
- Bortezomib 2.5 mg Injection, Powder, Lyophilized, For Solution NDC 68083-651-01
- Dexmedetomidine Hydrochloride 4 ug/mL Injection NDC 68083-657-10
- Selenious Acid 60 ug/mL Injection, Solution NDC 68083-660-05
- Acetazolamide 500 mg/5mL Injection, Powder, Lyophilized, For Solution NDC 68083-661-01
- Vasopressin .4 [USP'U]/mL Injection NDC 68083-663-10
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
⏱️ Dosage and Administration ▾
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 ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active ingredient Alcaftadine 0.25%
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid, water for injection
🎯 Purpose ▾
Purpose Antihistamine
📄 Do Not Use ▾
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 ▾
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 ▾
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 ▾
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Container Label - 0.25% (3 mL) NDC-68083-649-01 Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops 0.10 fl oz (3 mL) Sterile Container Carton - 0.25% (3 mL) ORIGINAL PRESCRIPTION STRENGTH NDC-68083-649-01 3 mL Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed 40 DAY SUPPLY Sterile 0.10 fl oz (3 mL) Container Carton - 0.25% (3 mL) - Twin Pack ORIGINAL PRESCRIPTION STRENGTH TWIN PACK NDC-68083-649-02 3 mL Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed 80 DAY SUPPLY Sterile Two 3 mL bottles (0.10 fl oz each) alcaftadine-spl-container-label alcaftadine-spl-carton-label-mono-pack alcaftadine-spl-carton-label-twin-pack
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Alcaftadine — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 21%
Female · 79%
Serious outcomes
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.
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 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: 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.
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.