Timolol Maleate 5 mg/mL Solution
by Oceanside Pharmaceuticals · 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING
NDC 68682-0813-05
🏷️ FDA NDC (as labeled)
68682-813-05
billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dispensing
Cost per mL$1.13 NADAC
Per package$5.64 / 5 ml
Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.08/unit — full pricing hub ↓
Also comes in:
10 mL 68682-0813-10
Rx only
Brand
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Timolol Maleate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 5, 2025 — Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0543-2025
Class II · Apr 18, 2025 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0403-2025
Class II · Jan 23, 2025 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0214-2025
Class II · Dec 5, 2024 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0114-2025
Class II · Oct 29, 2024 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0035-2025
Class II · Aug 12, 2024 — Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0642-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Nov 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
68682-813-05
Product NDC
68682-813
11-digit billing NDC
68682081305
NCPDP billing unit
ML — per mL (volume)
Application #
NDA018086
Established class (EPC)
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker
DEA schedule
Non-controlled
Marketing category
NDA AUTHORIZED GENERIC
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Nov 2025)
Route
OPHTHALMIC
Dosage form
SOLUTION
Substance
TIMOLOL MALEATE
GCN Seq No
007856
GCN
32821
HICL code
002105
Ingredient (HICL)
Timolol Maleate
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
Q6G
Therapeutic class — specific (HIC3)
Miotics And Other Intraocular Pressure Reducers
AHFS code
52:40.08.00
AHFS class
Beta-Adrenergic Blocking Agents (52:40)
FDB label name
TIMOLOL MALEATE 0.5% EYE DROPS
FDB brand name
Timolol Maleate
Legend status
F — Federal legend — prescription drug or device
TE code (Orange Book)
AT1 · RLD · RS
Why two NDCs?
The FDA registers this code as 68682-813-05 — 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 → 68682-0813-05. 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.
🏭 Manufacturer & labeler
LabelerOceanside Pharmaceuticals
Application holderBAUSCH AND LOMB INC
FDA applicationNDA018086 (NDA AUTHORIZED GENERIC)
Labeler code68682
Product typeHuman Prescription Drug
Portfolio87 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.
🩺 Clinical
Label name TIMOLOL MALEATE 0.5% EYE DROPS Ingredient Timolol Maleate
📗 Our plain-language guide HelloPharmacist
- Yes, and this is something your pharmacist and doctor take seriously. Even though you're putting the drops in your eye, a small amount is absorbed into your bloodstream. This can s...
- I was prescribed timolol eye drops for glaucoma. Can the drops affect my heart or breathing?
- Please don't stop on your own — this is one of the most important things to know about timolol tablets. Stopping suddenly, especially if you have any heart disease, can cause a dan...
- I take timolol tablets for high blood pressure. Is it safe to just stop if I feel fine?
Patient education
Supplement & herbal interactions
1
Nutrient depletion considerations
Timolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
💬 Questions about Timolol Maleate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 | $1.128 | $5.64 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.08 | $5.41 / 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
▼ Down 7% over the last 15 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 |
|---|---|---|---|---|---|---|
| Timolol Maleate 5 mg/mL 64980-0514-01 | Rising | 1 bottle | $0.732 | AT1 | Availability likely | save 35% |
| Timolol Maleate 5 mg/mL 65145-0153-01 | Caplin | 1 bottle | $0.732 | AT1 | Availability likely | save 35% |
| Timolol maleate 5 mg/mL 70069-0707-01 | Somerset | 1 bottle | $0.732 | AT1 | Availability likely | save 35% |
| timolol maleate 5 mg/mL 70756-0657-30 | Lifestar | 1 bottle | $0.732 | AT1 | Availability likely | save 35% |
| Timolol Maleate 5 mg/mL 65145-0154-01 | Caplin | 1 bottle | $0.760 | AT1 | Availability likely | save 33% |
| Timolol maleate 5 mg/mL 70069-0708-01 | Somerset | 1 bottle | $0.760 | AT1 | Availability likely | save 33% |
| Timolol Maleate 5 mg/mL 42571-0404-21 | Micro | 5 ml | $1.059 | AT1 | Availability likely | save 6% |
| Timolol Maleate 5 mg/mL 60758-0801-05 | Pacific | 1 bottle | $1.059 | AT1 | Availability likely | save 6% |
| Timolol Maleate 5 mg/mL 61314-0227-05 | Sandoz | 5 ml | $1.059 | AT1 | Availability likely | save 6% |
| Timolol Maleate 5 mg/mL 65145-0152-01 | Caplin | 1 bottle | $1.059 | AT1 | Availability likely | save 6% |
| Timolol Maleate 5 mg/mL 69315-0325-05 | Leading | 5 ml | $1.059 | AT1 | Availability likely | save 6% |
| Timolol maleate 5 mg/mL 70069-0706-01 | Somerset | 1 bottle | $1.059 | AT1 | Availability likely | save 6% |
| timolol maleate 5 mg/mL 70756-0656-15 | Lifestar | 1 bottle | $1.059 | AT1 | Availability likely | save 6% |
| timolol maleate 5 mg/mL 72603-0540-01 | NorthStar | 1 bottle | $1.059 | AT1 | Availability likely | save 6% |
| Timolol Maleate 5 mg/mL 82260-0813-05 | Bausch | 1 bottle | $1.059 | AT1 | Availability likely | save 6% |
| Timolol Maleate 5 mg/mLthis 68682-0813-05 | Oceanside | 1 bottle | $1.128 | AT1 | Discontinued | — |
| Timoptic 5 mg/mL 24208-0813-05 | Bausch | 1 bottle | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-3441-00 | A-S | 10 ml | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-5769-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-7837-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
| timolol maleate 5 mg/mL 81469-0210-05 | First | 1 bottle | — | AT1 | FDA listed | — |
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
🗺️ 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 68682-0813-05, 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 – Q3 2025 · 3 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
11
Units reimbursed last 4 qtrs
55
Gross reimbursed last 4 qtrs
$59.46
Avg / prescription
$5.41
Avg / unit
$1.0811
Latest quarter Q3 2025
0Rx
Medicaid pays / mL
$1.0811
gross reimbursed
vs
NADAC / mL
$1.1277
acquisition cost
=
Spread
−$0.0466
-4% 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 ⓘ
Fee-for-service · 0 Rx Managed care · 11 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.90.9
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 11 Rx · 55 units · $59 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Timolol Maleate — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Timolol Maleate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.78M
Claims incl. refills
718.9K
Beneficiaries
526.4K
Spend / beneficiary
$22.38
Spend / claim
$16.39
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 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 Timolol Maleate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 40%
Female · 59%
Unknown · 0%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68682-0813-05 You're viewing this | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING | $1.13 / mL | $5.64 | 2020-06-01 | Discontinued by firm |
| 68682-0813-10 | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING | — | — | 2020-06-01 | Discontinued by firm |
Pack size FAQ
What quantity is in NDC 68682-0813-05?
NDC 68682-0813-05 is listed by the FDA — 1 bottle, dispensing in 1 carton / 5 ml in 1 bottle, dispensing.
What NDC number is used to bill for this package of Timolol Maleate 5 mg/mL Solution?
Bill NDC 68682-0813-05 — the 11-digit billing format is 68682081305. 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.
🧭 About this NDC listing & data coverage
Finished prescription product
No longer marketed (per FDA listing data)
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| 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) | ✓ Available |
“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 full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 68682-813-05, 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: 68682-0813-05, written without dashes as 68682081305. 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 68682-0813-05, the first segment (68682) is the labeler code FDA assigned to Oceanside Pharmaceuticals; the middle segment (0813) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (68682-0813-10). 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?
Oceanside Pharmaceuticals 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.
📄 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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
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.
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.