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bimatoprost .3 mg/mL Solution/ Drops — NDC 46708-0511-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

bimatoprost .3 mg/mL Solution/ Drops — NDC 46708-511-05 (Billing 46708-0511-05)

by Alembic Pharmaceuticals Limited · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of bimatoprost .3 mg/mL Solution/ Drops from Alembic Pharmaceuticals Limited, marketed since Jul 2023 and currently FDA-listed.

NDC 46708-0511-05
🏷️ FDA NDC (as labeled) 46708-511-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $18.17/unit — full pricing hub ↓
Product page 46708-0511-03 Also comes in: 3 mL 46708-511-03
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 →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 46708-511-05
Product NDC 46708-511
11-digit billing NDC 46708051105
RxCUI 308739
UNII QXS94885MZ
Application # ANDA210515
SPL Set ID 2b4107e4-c108-4ed5-b7e8-253b74f2ff25
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 2023-07-21
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BIMATOPROST
TE code (Orange Book) AT · RLD · RS
Quick answers
  • RxCUI (RxNorm): 308739
Why two NDCs? The FDA registers this code as 46708-511-05 — 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 → 46708-0511-05. 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

📗 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 · Q2 2026 $18.17 $90.86 / 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
46708-0511-03 46708-511-03 Main listing 1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE 2023-07-21 — Active
46708-0511-05 You're viewing this 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2023-07-21 — 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 .3 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 .3 mg/mL 70069-0403-01 Somerset 1 bottle $4.207 AT Availability likely —
Bimatoprost .3 mg/mL 72266-0241-01 Fosun 1 bottle $4.207 AT Availability likely —
Bimatoprost .3 mg/mL 70069-0401-01 Somerset 1 bottle $6.969 AT Availability likely —
Bimatoprost .3 mg/mL 72266-0139-01 Fosun 1 bottle $6.969 AT Availability likely —
Bimatoprost .3 mg/mL 42571-0128-21 Micro 1 bottle $8.852 AT Availability likely —
Bimatoprost .3 mg/mL 60505-0583-01 Apotex 1 bottle $8.852 AT Availability likely —
Bimatoprost .3 mg/mL 62332-0507-05 Alembic 1 bottle $8.852 AT Availability likely —
Bimatoprost .3 mg/mL 65862-0802-05 Aurobindo 1 bottle $8.852 AT Availability likely —
Bimatoprost .3 mg/mL 70069-0402-01 Somerset 1 bottle $8.852 AT Availability likely —
Bimatoprost .3 mg/mL 72266-0140-01 Fosun 1 bottle $8.852 AT Availability likely —
Bimatoprost .3 mg/mL 00781-6206-75 Sandoz 1 bottle $20.649 AT Availability likely —
bimatoprost .3 mg/mL 62332-0511-03 Alembic 1 bottle $26.274 AT Availability likely —
Latisse .3 mg/mL 00023-3616-05 Allergan, 1 bottle $31.491 AT Availability likely —
Bimatoprost .3 mg/mL 46708-0507-05 Alembic 1 bottle — AT FDA listed —
bimatoprost .3 mg/mLthis 46708-0511-05 Alembic 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68071-3590-05 NuCare 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68071-3612-05 NuCare 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68083-0295-01 Gland 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68083-0296-01 Gland 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68083-0439-01 Gland 1 bottle — AT 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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.

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.

Manufacturer & labeler

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA210515 (ANDA)
Labeler code46708
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio502 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.

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Bimatoprost ophthalmic solution, for topical ophthalmic use is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

⏱️ Dosage and Administration 215 words ▾

2 DOSAGE AND ADMINISTRATION Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of bimatoprost ophthalmic solution, 0.03% on the disposable sterile applicator supplied with the package and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of lash growth should feel lightly moist without runoff.

Blot any excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.

Do not reuse applicators and do not use any other brush/applicator to apply bimatoprost ophthalmic solution 0.03%. Do not apply to the lower eyelash line [ see Warnings and Precautions (5.3, 5.4 ] and Patient Counseling Information (17)]. Additional applications of bimatoprost ophthalmic solution 0.03% will not increase the growth of eyelashes.

Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level. Apply nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying applicators. Blot any excess solution beyond the eyelid margin.

Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.

💊 Dosage Forms and Strengths 17 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing bimatoprost 0.3 mg/mL. Ophthalmic solution containing bimatoprost 0.3 mg/mL.

⛔ Contraindications 27 words ▾

4 CONTRAINDICATIONS Bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [ see Adverse Reactions 6.2) ]. Hypersensitivity

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Concurrent administration of Bimatoprost ophthalmic solution, for topical ophthalmic use and intraocular pressure (IOP)-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their IOP. ( 5.1 ) Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. ( 5.2, 5.3 )

5.1Effects on Intraocular Pressure Bimatoprost ophthalmic solution (LUMIGAN ® ) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, bimatoprost ophthalmic solution 0.03% lowered IOP, however, the magnitude of the reduction was not cause for clinical concern. In ocular hypertension studies with LUMIGAN ® , it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect.

In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution 0.03% may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN ® for IOP reduction should only use bimatoprost ophthalmic solution 0.03% after consulting with their physician and should be monitored for changes to their intraocular pressure.

5.2Iris Pigmentation Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent [see Adverse Reactions (6.2] . The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.

The long term effects of increased pigmentation are not known. Iris color changes seen with administration of bimatoprost ophthalmic solution 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. Treatment with bimatoprost ophthalmic solution 0.03% can be continued in patients who develop noticeably increased iris pigmentation.

5.3Lid Pigmentation Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.

5.4Hair Growth Outside the Treatment Area There is the potential for hair growth to occur in areas where bimatoprost ophthalmic solution 0.03% comes in repeated contact with the skin surface. It is important to apply bimatoprost ophthalmic solution 0.03% only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess bimatoprost ophthalmic solution 0.03% from the eyelid margin to avoid it running onto the cheek or other skin areas.

5.5Intraocular Inflammation Bimatoprost ophthalmic solution 0.03% should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

5.6Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution (LUMIGAN®) for elevated IOP. Bimatoprost ophthalmic solution 0.03% 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.

5.7Contamination of bimatoprost ophthalmic solution 0.03% or Applicator The Bimatoprost ophthalmic solution 0.03% bottle must be kept intact during use… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Effects on Intraocular Pressure [see Warnings and Precautions (5.1)] Iris Pigmentation [see Warnings and Precautions (5.2)] Lid Pigmentation [see Warnings and Precautions (5.3)] Hair Growth Outside the Treatment Area [see Warnings and Precautions (5.4)] Intraocular Inflammation [see Warnings and Precautions (5.5)] Macular Edema [see Warnings and Precautions (5.6)] Hypersensitivity [see Contraindications (4)] Most common adverse reactions (incidence approximately 3% to 4%) are eye pruritus, conjunctival hyperemia, and skin hyperpigmentation.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trial 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. The following information is based on clinical trial results from a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema.

These reactions occurred in less than 4% of patients. Additional adverse reactions seen in clinical trials experience include foreign body sensation, hair growth abnormal, and iris hyperpigmentation. Additional adverse reactions reported with bimatoprost ophthalmic solution (LUMIGAN ® ) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, eye pain, blepharitis, cataract, superficial punctate keratitis, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, conjunctival edema, iritis, infections (primarily colds and upper respiratory tract infections), headaches, and asthenia.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of bimatoprost ophthalmic solution 0.03%. 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. The reactions include dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few lashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus and eyelid ptosis, rash (including macular and erythematous), skin discoloration (periorbital), skin exfoliation of the eyelid and/or periorbital area, trichiasis, and vision blurred.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal development studies, administration 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC).

These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.

No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). The NOAEL for postnatal development and mating performance of the offspring wa… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal development studies, administration 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC).

These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.

No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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 following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac 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… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 128 words ▾

8.4Pediatric Use Use of bimatoprost ophthalmic solution 0.03% was evaluated in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. No new safety issues were observed. The results of the Global Eyelash Assessment (GEA) are provided in Table 1.

Table 1. Number (%) of subjects with at least a 1-grade increase from baseline at month 4 in Global Eyelash Assessment Age Range (years) Bimatoprost ophthalmic solution 0.03% Vehicle Difference (95% CI) Adolescents with hypotrichosis (N=40) 15-17 19/26 (73%) 1/14 (7%) 66% (44%, 88%) Post Chemotherapy Pediatric Patients (N=16) 5-17 11/13 (85%) 3/3 (100%) -15% (-35%, 4%) Alopecia Areata Pediatric Patients (N=15) 5-17 4/9 (44%) 2/6 (33%) 11% (-39%, 61%)

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown, the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.

12.3Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) 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. 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.

🧬 Mechanism of Action 42 words ▾

12.1Mechanism of Action Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown, the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.

📦 How Supplied / Storage and Handling 69 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low-density polyethylene round screw neck bottle and tips with high density polyethylene turquoise opaque screw cap accompanied by sterile, disposable applicators: 5 mL in a 5 mL bottle with 140 applicators NDC 46708-511-05 3 mL in a 5 mL bottle with 70 applicators NDC 46708-511-03 Storage: Store at 2° to 25°C (36° to 77°F).

📋 Description 124 words ▾

11 DESCRIPTION Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[( 1R, 2R, 3R, 5S )-3, 5-Dihydroxy-2-[(1E, 3S)-3-hydroxy-5-phenyl-1pentenyl] cyclopentenyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C 25 H 37 NO 4 .

Its chemical structure is: Bimatoprost is a powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution 0.03% is clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost Ophthalmic Solution 0.03% contains: Active : bimatoprost 0.3 mg/mL; Preservative : benzalkonium chloride 0.05 mg/mL; Inactives : sodium chloride; sodium phosphate, dibasic; citric acid; 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 to7.8. bimatoprost-struc

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Nightly Application Inform patients that bimatoprost ophthalmic solution, 0.03% should be applied every night using only the accompanying sterile applicators. They should start by ensuring their face is clean, all makeup is removed, and their contact lenses removed (if applicable). Then, carefully place one drop of bimatoprost ophthalmic solution, 0.03% on the disposable sterile applicator and brush cautiously along the skin of the upper eyelid margin at the base of the eyelashes.

If any bimatoprost ophthalmic solution, 0.03% gets into the eye proper, it will not cause harm. The eye should not be rinsed. Additional applications of bimatoprost ophthalmic solution, 0.03% will not increase the growth of eyelashes.

Inform patients not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material. The onset of effect is gradual but is not significant in the majority of patients until 2 months.

Counsel patients that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with bimatoprost ophthalmic solution, 0.03%. Handling the Bottle and Applicator Instruct patients that the bimatoprost ophthalmic solution, 0.03% bottle must be maintained intact and to avoid allowing the tip of the bottle or applicator to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination of the bottle or applicator by common bacteria known to cause ocular infections.

Instruct patients to only use the applicator supplied with the product once and then discard since reuse could result in using a contaminated applicator. Serious infections may result from using contaminated solutions or applicators. Potential for Intraocular Pressure Effects Bimatoprost ophthalmic solution, 0.03% may lower intraocular pressure although not to a level that will cause clinical harm.

In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution, 0.03% may interfere with the desired reduction in IOP. Patients using prostaglandin analogs for IOP reduction should only use bimatoprost ophthalmic solution, 0.03% after consulting with their physician. Potential for Eyelid Skin Darkening Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution, 0.03%.

Potential for Iris Darkening Advise patients about the potential for increased brown iris pigmentation which is likely to be permanent. Increased iris pigmentation has occurred when bimatoprost solution was administered. Potential for Unexpected Hair Growth or Eyelash Changes Inform patients of the possibility of hair growth occurring outside of the target treatment area if bimatoprost ophthalmic solution, 0.03% repeatedly touches the same area of skin outside the treatment area.

They should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are likely reversible upon discontinuation of treatment. When to Seek Physician Advice Advise patients that if they develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, 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, 0.03%.

Patients on IOP-lowering medications should not use bimatoprost ophthalmic solution, 0.03% without prior consultation with their physician. Contact Lens Use Advise patients that bimatoprost ophthalmic solution, 0.03% contain… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 110 words ▾

8.2Lactation Risk Summary It is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.03% 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) 324 times the recommended human ophthalmic dose (on a mg/m 2 basis), however no animal data is available at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bimatoprost ophthalmic solution 0.03% and any potential adverse effects on the breastfed child from bimatoprost ophthalmic solution 0.03%.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) 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. 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.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES Bimatoprost ophthalmic solution, 0.03% was evaluated for its effect on overall eyelash prominence in a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The primary efficacy endpoint in this study was an increase in overall eyelash prominence as measured by at least a 1-grade increase on the 4-point Global Eyelash Assessment (GEA) scale, from baseline to the end of the treatment period (week 16). Bimatoprost ophthalmic solution, 0.03% was more effective than vehicle as measured by the GEA score, with statistically significant differences seen at 8-week, 12-week, and 16-week ( primary endpoint ) treatment durations.

Table 2 Number (%) of subjects with at least a 1-grade increase from baseline in Global Eyelash Assessment (Primary Efficacy Endpoint – Week 16) Week Bimatoprost ophthalmic solution, 0.03% N=137 N (%) Vehicle N= 141 N (%) 1 7 (5%) 3 (2%) 4 20 (15%) 11 (8%) 8 69 (50%) 21 (15%) 12 95 (69%) 28 (20%) 16 107 (78%) 26 (18%) 20 103 (79%) 27 (21%) In this study, patients were also evaluated for the effect of bimatoprost ophthalmic solution, 0.03% on the length, thickness and darkness of their eyelashes. Improvements from baseline in eyelash growth as measured by digital image analysis assessing eyelash length, fullness/thickness, and darkness were statistically significantly more pronounced in the bimatoprost group at weeks 8, 12, and 16.

Table 3 Efficacy endpoint at Week 16 (Mean Change from Baseline) Bimatoprost ophthalmic solution 0.03% Vehicle Eyelash growth (length) (mm; % increase) N=137 1.4; 25% N=141 0.1; 2% Fullness/thickness (mm 2 ; % increase) N=136 0.7; 106% N=140 0.1; 12% Eyelash darkness (intensity*; % increase in darkness) N=135 -20.2; -18% N=138 -3.6;-3% * a negative value is representative of eyelash darkening After the 16-week treatment period, a 4-week post-treatment period followed during which the effects of bimatoprost started to return toward baseline.

The effect on eyelash growth is expected to abate following longer term discontinuation.

🧪 Nonclinical Toxicology 138 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis and Mutagenesis and Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (approximately 192 and 291 times the human systemic exposure following topical administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily 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(103 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 135 words ▾

13.1Carcinogenesis and Mutagenesis and Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (approximately 192 and 291 times the human systemic exposure following topical administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily 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(103 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels).

📄 Patient Package Insert 1 words ▾

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📄 Package Label / Principal Display Panel 67 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 5 mL - Alembic: B imatoprost ophthalmic solution 0.03% Topical - Carton label - 5mL - Alembic : Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 3 mL - Alembic : B imatoprost ophthalmic solution 0.03% Topical - Carton label - 3mL - Alembic : Bottle-label-5 mL Carton -Label-5 mL Bottle-Label-3 mL Container-Label-3mL

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Alembic Pharmaceuticals 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 (46708-0511-03). 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?
Alembic Pharmaceuticals 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 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.
← 46708-0508-17 · Alembic 46708-0518-05 · Alembic →
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.