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Bimatoprost .1 mg/mL Solution/ Drops — NDC 81469-0291-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bimatoprost .1 mg/mL Solution/ Drops — NDC 81469-291-05 (Billing 81469-0291-05)

by First Nation Group, LLC · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Bimatoprost .1 mg/mL Solution/ Drops from First Nation Group, LLC, marketed since May 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 81469-0291-05
🏷️ FDA NDC (as labeled) 81469-291-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 81469-291 · Also comes in: 2.5 mL 81469-291-25
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 81469-291-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
81469 labeler · 291 product · 05 package
Package marketed since
May 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8146929105 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81469-291-05
Product NDC 81469-291
11-digit billing NDC 81469029105
NCPDP billing unit ML — per mL (volume)
RxCUI 1009339
UNII QXS94885MZ
Application # ANDA218196
SPL Set ID 6a74ad65-dd76-45c1-9bbe-4218a9978b70
Established class (EPC) Prostaglandin Analog
Chemical class Prostaglandins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BIMATOPROST
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86330015002010
GCN Seq No 065392
GCN 27131
HICL code 022000
Ingredient (HICL) Bimatoprost
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 52:40.28.00
AHFS class Prostaglandin Analogs
FDB label name BIMATOPROST 0.01% EYE DROPS
FDB brand name Bimatoprost
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 065392
  • GCN: 27131
  • GPI-14 (Medi-Span): 86330015002010
  • HICL (First Databank): 022000
  • AHFS class code: 52:40.28.00
  • RxCUI (RxNorm): 1009339
Why two NDCs? The FDA registers this code as 81469-291-05 — 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 → 81469-0291-05. 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 Prostaglandin Analog class.

Pharmacologic class Prostaglandin Analog
Drug family (ATC) Prostaglandin analogues
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.

Clinical

Label name BIMATOPROST 0.01% EYE DROPS Ingredient Bimatoprost
📖 What it is MedlinePlus · NLM

Bimatoprost ophthalmic is used to treat glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) and ocular hypertension (a condition which causes increased pressure in the eye). Bimatoprost is in a class of medications called prostaglandin analogs. It lowers pressure in the eye by increasing the flow of natural eye fluids out of the eye.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product you have. Lumigan, Zolymbus and Durysta lower high eye pressure in open-angle glaucoma or ocular hypertension. Latisse and generic bimatoprost 0.03% are f...
  • Lumigan and Zolymbus are one drop in the eye once daily in the evening. Latisse and generic bimatoprost 0.03% go on the upper eyelid margin once nightly with a fresh sterile applic...
  • Red, itchy or dry eyes are common, and you may notice lash growth or darker skin around the eye. Most of these are mild. Call me or your doctor if you have eye pain, vision changes...
  • Yes. It can make the iris more brown, and this is likely to be permanent. It may take months or years to notice. Your doctor can talk with you about this.
📖 Read our full Bimatoprost guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Bimatoprost — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Bimatoprost (3 interactions) — ranked by severity →
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.

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: 2.5 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
81469-0291-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2026-05-01 — Active
81469-0291-25 81469-291-25 1 BOTTLE in 1 CARTON / 2.5 mL in 1 BOTTLE 2026-05-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 5 ml in 1 bottle.
What NDC number is used to bill for this package of Bimatoprost .1 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bimatoprost .1 mg/mL 60219-2149-01 Amneal 1 bottle $42.516 AB Availability likely —
Bimatoprost .1 mg/mL 70756-0626-30 Lifestar 1 bottle $42.516 AB Availability likely —
Bimatoprost .1 mg/mL 70756-0627-30 Lifestar 1 bottle $42.752 AB Availability likely —
Bimatoprost .1 mg/mL 70756-0628-30 Lifestar 1 bottle $43.413 AB Availability likely —
Lumigan .1 mg/mL 00023-3205-02 Allergan, 1 bottle — AB FDA listed —
Bimatoprost .1 mg/mLthis 81469-0291-05 First 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
May 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.

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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical 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 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.

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.

Manufacturer & labeler

LabelerFirst Nation Group, LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA218196 (ANDA)
Labeler code81469
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio18 products on file

More NDCs from First Nation Group, LLC labeler code 81469

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE Bimatoprost ophthalmic solution 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. (1)

⏱️ Dosage and Administration 124 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. Bimatoprost ophthalmic solution 0.01% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours.

Bimatoprost ophthalmic solution 0.01% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. One drop in the affected eye(s) once daily in the evening.

(2)

💊 Dosage Forms and Strengths 19 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing bimatoprost 0.1 mg/mL. Ophthalmic solution containing 0.1 mg/mL of bimatoprost. (3)

⛔ Contraindications 26 words ▾

4 CONTRAINDICATIONS Bimatoprost ophthalmic solution 0.01% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2)]. Hypersensitivity. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. (5.1) Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. (5.2)

5.1Pigmentation Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered.

The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation.

The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.

Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with bimatoprost ophthalmic solution 0.01% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

5.2Eyelash Changes Bimatoprost ophthalmic solution 0.01% may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

5.3Intraocular Inflammation Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. In addition, because these products may exacerbate inflammation, caution should be used in patients with active intraocular inflammation (e.g., uveitis).

5.4Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. Bimatoprost ophthalmic solution 0.01% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

5.5Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

5.6Contact Lens Use Bimatoprost ophthalmic solution 0.01% contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to instillation of bimatoprost ophthalmic solution 0.01% and may be reinserted 15 minutes following its administration.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Pigmentation including blepharal pigmentation and iris hyperpigmentation [see Warnings and Precautions (5.1)] Eyelash Changes [see Warnings and Precautions (5.2)] Intraocular Inflammation [see Warnings and Precautions (5.3)] Macular Edema [see Warnings and Precautions (5.4)] Hypersensitivity [see Contraindications (4)] Most common adverse reaction (31%) is conjunctival hyperemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact First Nation Group, LLC at 1-855-221-5332 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia.

Other adverse drug reactions (reported in 1 to 4% of patients) with bimatoprost ophthalmic solution 0.01% in this study included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, and visual acuity reduced.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of bimatoprost ophthalmic solution 0.01%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to bimatoprost ophthalmic solution, or a combination of these factors include: asthma-like symptoms, dizziness, dry eye, dyspnea, eye discharge, eye edema, foreign body sensation, headache, hypersensitivity including signs and symptoms of eye allergy and allergic dermatitis, hypertension, lacrimation increased, periorbital and lid changes associated with periorbital fat atrophy leading to skin tightness, deepening of the eyelid sulcus, eyelid ptosis, enophthalmos, and eyelid retraction; and photophobia.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. (8.4)

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.01% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal developmental studies, administraton of bimatoprost to pregnant mice and rats during organogenesis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure to bimatoprost 0.03% dosed bilaterally once daily (based on blood area under the curve [AUC] levels).

These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure to bimatoprost 0.03% dosed bilaterally once daily (based on blood AUC levels). In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily (based on blood AUC levels).

No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure to bimatoprost 0.03% dosed bilaterally once daily (based on blood AUC levels). Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.01% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, based on AUC).

The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, based on AUC).

The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day.

These effects were observed at exposures at least 41 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, based on AUC).

8.2Lactation Risk Summary It is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.01% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 970 times… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 69 words ▾

10 OVERDOSAGE No information is available on overdosage in humans. If overdose with bimatoprost ophthalmic solution 0.01% occurs, treatment should be symptomatic. In oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m 2 is at least 210 times higher than the accidental dose of one bottle of bimatoprost ophthalmic solution 0.01% for a 10 kg child.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. It selectively mimics the effects of naturally occurring substances, prostamides. Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes.

Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

12.3Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily to both eyes of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C max and AUC 0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng•hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing.

There was no significant systemic drug accumulation over time. Distribution Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of

0.67L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.

Elimination Metabolism Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites. Excretion Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes.

The total blood clearance of bimatoprost was

1.5L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.

📦 How Supplied / Storage and Handling 87 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost ophthalmic solution 0.01% is supplied as sterile, clear, and colorless solution in opaque white high density polyethylene bottles with white low density polyethylene nozzle and high density polyethylene turquoise caps in the following sizes: 2.5 mL fill in a 10 mL container - NDC 81469-291-25 5 mL fill in a 10 mL container - NDC 81469-291-05 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, bimatoprost ophthalmic solution 0.01% can be used until the expiration date on the bottle.

📋 Description 131 words ▾

11 DESCRIPTION Bimatoprost ophthalmic solution 0.01% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is ( Z )-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5-heptenamide, and its molecular weight is 415.6. Its molecular formula is C 25 H 37 NO 4 .

Its chemical structure is: Bimatoprost is a white or almost white crystalline powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution 0.01% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.01% contains Active: bimatoprost 0.1 mg/mL; Preservative: benzalkonium chloride 0.2 mg/mL; Inactives: boric acid, glycerin, sodium borate, and water for injection.

Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8. structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Also inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution 0.01%. Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with bimatoprost ophthalmic solution 0.01%.

These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. Handling the Container Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections.

Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of bimatoprost ophthalmic solution 0.01%. Contact Lens Use Advise patients that bimatoprost ophthalmic solution 0.01% contains benzalkonium chloride, which may be absorbed by soft contact lenses.

Contact lenses should be removed prior to instillation of bimatoprost ophthalmic solution 0.01% and may be reinserted 15 minutes following its administration. Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. Manufactured for: First Nation Group, LLC 4566 E Highway 20 Suite #208 Niceville, FL 32578-8839 Product of Italy Revised: April 2026, V-01

🔬 Clinical Studies 43 words ▾

14 CLINICAL STUDIES In a 12-month clinical study of patients with open angle glaucoma or ocular hypertension with an average baseline IOP of 23.5 mmHg, the IOP-lowering effect of bimatoprost ophthalmic solution 0.01% once daily (in the evening) was up to 7.5 mmHg.

🧪 Nonclinical Toxicology 122 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses up to 2 mg/kg/day and 1 mg/kg/day, respectively (192 and 291 times the estimated human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, respectively, based on blood AUC levels) Mutagenesis Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.

Impairment of Fertility Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day (at least 103 times the recommended human exposure to bimatoprost 0.03% dosed bilaterally once daily based on blood AUC levels).

📄 Package Label / Principal Display Panel 71 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 81469-291-25 Bimatoprost Ophthalmic Solution 0.01% For eye use only 2.5 mL Rx only Sterile NDC 81469-291-25 Bimatoprost Ophthalmic Solution 0.01% For eye use only 2.5 mL Rx only Sterile NDC 81469-291-05 Bimatoprost Ophthalmic Solution 0.01% For eye use only 5 mL Rx only Sterile NDC 81469-291-05 Bimatoprost Ophthalmic Solution 0.01% For eye use only 5 mL Rx only Sterile 2.5 ml bottle label 2.5mlcarton 5mlbottle 5mlcarton

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Bimatoprost — the program that covers self-administered drugs. 6 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 Bimatoprost. 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
$1.7M
Claims incl. refills
22.9K
Beneficiaries
16.6K
Spend / beneficiary
$102.47
Spend / claim
$73.99
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.

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 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 First Nation Group, LLC. 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 (81469-0291-25). 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?
First Nation Group, LLC 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.
← 81469-0223-01 · First 81469-0353-01 · First →
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.