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Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL Solution/ Drops — NDC 73043-0029-01 package photo

Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL Solution/ Drops

by Devatis Inc. · 1 BOTTLE, DROPPER in 1 CARTON (73043-029-01) / 5 mL in 1 BOTTLE, DROPPER
NDC 73043-0029-01
🏷️ FDA NDC (as labeled) 73043-029-01 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dropper Pack sizes2 compare ↓
Also comes in: 10 mL 73043-0029-02
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 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

⚠️
Other active recalls for Brimonidine Tartrate And Timolol Maleate (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 5, 2026 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0407-2026
Class II · Sep 5, 2025 — Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns (Apotex Corp.) · FDA recall D-0676-2025
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0496-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 73043-029-01
Product NDC 73043-029
11-digit billing NDC 73043002901
Application # ANDA217934
SPL Set ID ed315996-a7a7-4609-9f3e-92e6aba139fe
Established class (EPC) alpha-Adrenergic Agonist; beta-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-15
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BRIMONIDINE TARTRATE; TIMOLOL MALEATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 73043-029-01 — 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 → 73043-0029-01. 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.

🏭 Manufacturer & labeler

LabelerDevatis Inc.
Application holderSABA ILAC SANAYIVE TICARET AS
FDA applicationANDA217934 (ANDA)
Labeler code73043
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio14 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

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 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 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 GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • 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.

5 inactive ingredients listed in the exact product block matched to this NDC.

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 systemPer mLPer 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: 10 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0164-01 Caplin 1 bottle $1.839 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0653-01 Somerset 1 bottle $1.839 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0652-01 Somerset 1 bottle $2.461 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0163-01 Caplin 1 bottle $2.461 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 00781-7186-70 Sandoz 10 ml $2.461 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate 2 mg/mL; 5 mg/mL 68462-0281-32 Glenmark 1 bottle $2.461 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 00832-1425-05 Upsher-Smith 1 bottle $2.795 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 69315-0330-05 Leading 1 bottle $2.795 AB Availability likely —
Brimonidine Tartrate And Timolol Maleate 2 mg/mL; 5 mg/mL 71921-0188-05 Florida 1 bottle $2.795 AB Availability likely —
Brimonidine tartrate and Timolol maleate 2 mg/mL; 5 mg/mL 72603-0931-05 NorthStar 1 bottle $2.795 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 60505-0589-01 Apotex 1 bottle $2.795 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 62332-0706-05 Alembic 1 bottle $2.795 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0651-01 Somerset 1 bottle $2.795 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0162-01 Caplin 1 bottle $2.795 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 46708-0706-05 Alembic 1 bottle — AB FDA listed —
Brimonidine Tartrate/Timolol Maleate 2 mg/mL; 5 mg/mL 72485-0634-05 ARMAS 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0664-01 Gland 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0625-01 Gland 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0624-01 Gland 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mLthis 73043-0029-01 Devatis 1 bottle — AB 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 Brimonidine Tartrate and Timolol maleate Ophthalmic Solution (this brand).

Top reported reactions

Blindness4
Eye Disorder4
Blindness Unilateral3
Ocular Hyperaemia3
Death2
Dry Eye2
Eye Pain2

Age at onset

Adult1

Reporter sex

0 reports

Serious outcomes

Disabling2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 7 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
73043-0029-01 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (73043-029-01) / 5 mL in 1 BOTTLE, DROPPER 2026-09-15 Active
73043-0029-02 1 BOTTLE, DROPPER in 1 CARTON (73043-029-02) / 10 mL in 1 BOTTLE, DROPPER 2026-09-15 Active

Pack size FAQ

What quantity is in NDC 73043-0029-01?
NDC 73043-0029-01 is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL Solution/ Drops?
Bill NDC 73043-0029-01 — the 11-digit billing format is 73043002901. 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

Finished prescription 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 ✓ 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) — 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 73043-029-01, 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: 73043-0029-01, written without dashes as 73043002901. 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 73043-0029-01, the first segment (73043) is the labeler code FDA assigned to Devatis Inc.; the middle segment (0029) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Devatis Inc.. 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 (73043-0029-02). 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?
Devatis Inc. 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
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 73043-0024-01 · Devatis 73043-0034-05 · Devatis →
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.