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VUITY Pilocarpine Hydrochloride 12.5 mg/mL Solution/ Drops, 3 bottles — NDC 00074-7098-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

VUITY Pilocarpine Hydrochloride 12.5 mg/mL Solution/ Drops, 3 bottles — NDC 0074-7098-03 (Billing 00074-7098-03)

by AbbVie Inc. · 3 BOTTLE in 1 BOX / 2.5 mL in 1 BOTTLE

This is a package of 3 bottles of VUITY Pilocarpine Hydrochloride 12.5 mg/mL Solution/ Drops from AbbVie Inc., no longer marketed (first marketed Oct 2021), no longer in the FDA NDC Directory.

NDC 00074-7098-03
🏷️ FDA NDC (as labeled) 0074-7098-03 billing pads the labeler segment with a zero
This package
Contains3 bottles Pack sizes5 compare ↓
Product page 00074-7098-04 Also comes in: 2.5 mL 0074-7098-01 2.5 mL 0074-7098-04 1.5 mL 0074-7098-05 5 mL 0074-7098-06
Rx only Brand Discontinued Non-controlled ⚠ On shortage ⚠ Discontinued by firm ⇄ 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 0074-7098-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0074 labeler · 7098 product · 03 package
Barcode (UPC-A, from the NDC)
3 0074709803 3
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Pilocarpine Hydrochloride Ophthalmic Solution is currently reported in shortage by the FDA. Shortage details →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0074-7098-03
Product NDC 0074-7098
11-digit billing NDC 00074709803
RxCUI 2584552, 2584557
UNII 0WW6D218XJ
Application # NDA214028
SPL Set ID 8d806897-8a2a-4518-8c68-0ec3b778de50
Established class (EPC) Cholinergic Receptor Agonist
Mechanism of action Cholinergic Agonists; Cholinergic Muscarinic Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2021-10-28
Marketing end 2026-09-30
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance PILOCARPINE HYDROCHLORIDE

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

GPI-14 86501030102017
GPI class Vuity
Quick answers
  • GPI-14 (Medi-Span): 86501030102017
  • RxCUI (RxNorm): 2584552
Why two NDCs? The FDA registers this code as 0074-7098-03 — a 4-4-2 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 labeler segment → 00074-7098-03. 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 Cholinergic Receptor Agonist class.

Pharmacologic class Cholinergic Receptor Agonist
Drug family (ATC) Other parasympathomimetics, Parasympathomimetics
How it works Cholinergic Muscarinic Agonists, Cholinergic Agonists
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

📖 What it is MedlinePlus · NLM

Pilocarpine 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). Pilocarpine ophthalmic is also used to prevent or reduce increased pressure in the eye during and after certain types of laser eye surgery. It is also used during an eye exam to constrict (close) the pupil (the black part of the eye through which you see). Pilocarpine ophthalmic (Vuity, Qlosi) is used to treat presbyopia (a condition in which the lens of the eye loses its abilit...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Pilocarpine drops lower high pressure inside the eye in open-angle glaucoma and ocular hypertension. They also help manage acute angle-closure glaucoma, help prevent pressure spike...
  • You put a drop in the affected eye(s), generally up to four times a day, as your prescriber directs. After the drop, you can press gently on the inner corner of your eye for 2 minu...
  • Take your lenses out before putting in the drops. Wait 10 minutes after dosing before putting them back in.
  • Headache, red eyes and eye irritation are the most common. Some people have blurred or dim vision, eye pain or watery eyes. If your vision is not clear, avoid driving or using mach...
📖 Read our full Pilocarpine Ophthalmic guide →

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.

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 2.5 mL 1.5 mL 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 Per unit Per pack Marketing startMarketing endStatus
00074-7098-01 0074-7098-01 1 BOTTLE in 1 BOX / 2.5 mL in 1 BOTTLE — — 2021-10-28 — Discontinued by firm
00074-7098-03 You're viewing this 3 BOTTLE in 1 BOX / 2.5 mL in 1 BOTTLE — — 2021-10-28 — Discontinued by firm
00074-7098-04 0074-7098-04 Main listing 1 BOTTLE in 1 CARTON / 2.5 mL in 1 BOTTLE $31.39 / mL $78.48 2021-10-28 Sep 30, 2026 Discontinued by firm
00074-7098-05 0074-7098-05 1 BOTTLE in 1 CARTON / 1.5 mL in 1 BOTTLE — — 2021-10-28 — Discontinued by firm
00074-7098-06 0074-7098-06 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE $23.39 / mL $116.97 2023-03-08 Sep 30, 2026 Discontinued by firm

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 3 bottles — 3 bottle in 1 box / 2.5 ml in 1 bottle.
How does this package differ from NDC 00074-7098-01?
Both are VUITY Pilocarpine Hydrochloride 12.5 mg/mL Solution/ Drops — the drug itself is identical. This page's package is the 3 bottles one, while NDC 00074-7098-01 is the 1 bottle package.
What NDC number is used to bill for this package of VUITY Pilocarpine Hydrochloride 12.5 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL 60219-2649-01 Amneal 1 bottle $19.391 — Availability likely —
Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL 60219-2366-02 Amneal 1 bottle $24.740 — Availability likely —
Vuity 12.5 mg/mLthis 00074-7098-03 AbbVie 3 bottles — — Discontinued —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2021
First FDA approval
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 28, 2021 RLD RS ⏳ ~12.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10610518 — method of use (U-3562)
US 10610518 — method of use (U-3561)
US 11285134 — method of use (U-3561)
US 11285134 — method of use (U-3562)
US 11285134 — method of use (U-3252)
US 10610518 — method of use (U-3252)
Exclusivity D-187
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 10610518 ↗ Method of use U-3562 Apr 24, 2039
US 10610518 ↗ Method of use U-3561 Apr 24, 2039
US 11285134 ↗ Method of use U-3561 Apr 24, 2039
US 11285134 ↗ Method of use U-3562 Apr 24, 2039
US 11285134 ↗ Method of use U-3252 Apr 24, 2039
US 10610518 ↗ Method of use U-3252 Apr 24, 2039
FDA exclusivity
CodeWhat it grantsExpires
D-187Other change requiring clinical data (3-year)Mar 28, 2026
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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

LabelerAbbVie Inc.
Application holderABBVIE INC
FDA applicationNDA214028 (NDA)
Labeler code00074
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio129 products on file

More NDCs from AbbVie Inc. labeler code 00074

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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

1 INDICATIONS AND USAGE VUITY ® is indicated for the treatment of presbyopia in adults. VUITY is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults. ( 1 )

⏱️ Dosage and Administration 86 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of VUITY is one drop in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.

Instill one drop of VUITY in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. ( 2 )

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS VUITY (pilocarpine hydrochloride ophthalmic solution) is a clear, colorless, sterile ophthalmic solution containing 1.25% (12.5 mg/mL) of pilocarpine hydrochloride. Ophthalmic solution containing pilocarpine hydrochloride 1.25%. ( 3 )

⛔ Contraindications 24 words ▾

4 CONTRAINDICATIONS VUITY is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Blurred Vision : Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination. ( 5.1 ) Risk of Retinal D etachment : Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY.

Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss.

( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 )

5.1Blurred Vision Miotics, including VUITY, may cause accommodative spasm. Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). In addition, patients may experience temporary dim or dark vision with miotics, including VUITY.

Patients should be advised to exercise caution in night driving and other hazardous activities in poor illumination. 5. 2 Risk of Retinal D etachment Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY.

Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to the initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss.

5. 3 Iritis VUITY is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens. 5.

4 Use with Contact Lenses Contact lens wearers should be advised to remove their lenses prior to the instillation of VUITY and to wait 10 minutes after dosing before reinserting their contact lenses. 5. 5 Potential for Eye Injury or Contamination To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications ( 4 )] Most common adverse reactions (>5%) are headache, conjunctival hyperemia, and eye irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 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. VUITY dosed once daily was evaluated in 375 participants with presbyopia in two randomized, double-masked, vehicle-controlled studies (GEMINI 1 and GEMINI 2) of 30 days duration. The most common adverse reactions reported in >5% of participants were headache and conjunctival hyperemia.

Ocular adverse reactions reported in 1-5% of participants were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation. VUITY was also evaluated in 114 participants with presbyopia in a randomized, double-masked, vehicle-controlled 14-day study (VIRGO) in which participants received two doses of VUITY in each eye, 6 hours apart daily. The most common adverse reactions reported in >5 % of participants were headache and eye irritation.

Ocular adverse reactions reported in 1-5% of participants were visual impairment, eye pain, blurred vision, and vitreous floaters.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of VUITY. 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 VUITY exposure. Eye disorders : vitreous detachment, vitreomacular traction, retinal tear, retinal detachment.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of VUITY administration in pregnant women to inform a drug-associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses. Data Human Data No adequate and well-controlled trials of VUITY have been conducted in pregnant women.

In a retrospective case series of 15 women with glaucoma, 4 patients used ophthalmic pilocarpine either pre-pregnancy, during pregnancy or postpartum. There were no adverse effects observed in patients or in their infants. Animal Data In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 485-fold higher than the maximum human ophthalmic dose [MHOD] of 0.03 mg/kg/day assuming administration of 2 drops/eye/day, on a mg/m 2 basis).

In a peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 195-fold higher than the MHOD). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥18 mg/kg/day (approximately 100 times the maximum human ophthalmic dose of VUITY).

8.2Lactation Risk Summary There is no information regarding the presence of pilocarpine in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of VUITY to an infant during lactation. Pilocarpine and/or its metabolites are excreted in the milk of lactating rats. Systemic levels of pilocarpine following topical ocular administration are low [see Clinical Pharmacology ( 12.3 ) ] , and it is not known whether measurable levels of pilocarpine would be present in maternal milk following topical ocular administration.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VUITY and any potential adverse effects on the breastfed child from VUITY. Data Animal Data Following a single oral administration of 14 C-pilocarpine to lactating rats, the radioactivity concentrations in milk were similar to those in plasma.

8.4Pediatric Use Presbyopia does not occur in the pediatric population.

8.5Geriatric Use Clinical studies of VUITY did not include participants aged 65 and over to determine whether they respond differently from younger participants. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger participants.

🤰 Pregnancy 197 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of VUITY administration in pregnant women to inform a drug-associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses. Data Human Data No adequate and well-controlled trials of VUITY have been conducted in pregnant women.

In a retrospective case series of 15 women with glaucoma, 4 patients used ophthalmic pilocarpine either pre-pregnancy, during pregnancy or postpartum. There were no adverse effects observed in patients or in their infants. Animal Data In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 485-fold higher than the maximum human ophthalmic dose [MHOD] of 0.03 mg/kg/day assuming administration of 2 drops/eye/day, on a mg/m 2 basis).

In a peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 195-fold higher than the MHOD). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥18 mg/kg/day (approximately 100 times the maximum human ophthalmic dose of VUITY).

🧒 Pediatric Use 11 words ▾

8.4Pediatric Use Presbyopia does not occur in the pediatric population.

🧓 Geriatric Use 44 words ▾

8.5Geriatric Use Clinical studies of VUITY did not include participants aged 65 and over to determine whether they respond differently from younger participants. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger participants.

🆘 Overdosage 76 words ▾

10 OVERDOSAGE Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity. Accidental ingestion can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration.

For patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. VUITY contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. VUITY also contracts the ciliary muscle and may shift the eye to a more myopic state.

12.3Pharmacokinetics Systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of VUITY in each eye once daily for 30 days (GEMINI 1). The mean (SD) C max and AUC values from time 0 to last measurable concentration over 10-hour period post-last dose on Day 30 were 1.95 (0.98) ng/mL and 4.14 (2.16) ng·hr/mL, respectively. The median T max value on Day 30 was 0.3 hours postdose with a range from 0.2 to 0.5 hours postdose.

Systemic exposure to pilocarpine was also evaluated in 8 participants with presbyopia who were administered 1 drop of VUITY in each eye twice daily for 14 days (VIRGO). The Day 14 mean (SD) C max following first daily dosing was 1.81 (0.51) ng/mL and following second daily dosing was 2.12 (1.75) ng/mL. The Day 14 mean (SD) AUC over 6-hour post-dose following first daily dose was 4.35 (1.50) ng·hr/mL and following second daily dose was 4.22 (3.14) ng·hr/mL.

There was no significant systemic drug accumulation over time, with accumulation index ratios between Day 1 and Day 14 based on AUC as 1.42 and 1.03 for the first and second daily dose, respectively.

🧬 Mechanism of Action 67 words ▾

12.1Mechanism of Action Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. VUITY contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. VUITY also contracts the ciliary muscle and may shift the eye to a more myopic state.

📦 How Supplied / Storage and Handling 107 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VUITY is supplied as an isotonic, clear, colorless sterile ophthalmic solution in colorless low density polyethylene (LDPE) ophthalmic dispenser bottles and tips, with dark green high impact polystyrene caps as follows: 2.5 mL fill in 5 mL bottle (Box containing 1 bottle) NDC 0074-7098-01 2.5 mL fill in 5 mL bottle (Box containing 3 bottles) NDC 0074-7098-03 2.5 mL fill in 5 mL bottle (Carton containing 1 bottle) NDC 0074-7098-04 5 mL fill in 5 mL bottle (Carton) NDC 0074-7098-06 Storage Store at 15°C to 25°C (59°F to 77°F).

After opening, VUITY can be used until the expiration date on the bottle.

📋 Description 124 words ▾

11 DESCRIPTION VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, clear, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride. The chemical name for pilocarpine hydrochloride is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]oxolan-2-one hydrochloride. Its molecular weight is 244.72 and its molecular formula is C 11 H 16 N 2 O 2 · HCl.

Its structural formula is: Each mL of VUITY contains pilocarpine hydrochloride 1.25% (12.5 mg) as the active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative is: benzalkonium chloride 0.0075%. Inactive ingredients in the ophthalmic solution are: boric acid, sodium citrate dihydrate, sodium chloride, purified water, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary. structural formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Night Driving VUITY may cause temporary dim or dark vision. Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination [see Warnings and Precautions ( 5.1 )] . Accommodative Spasm Temporary problems when changing focus between near and distant objects may occur.

Advise patients not to drive or use machinery if vision is not clear (e.g., blurred vision) [see Warnings and Precautions ( 5.1 )] . When to Seek Physician Advice Advise patients to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss [see Warnings and Precautions ( 5.2 )] . Contact Lens Wear Contact lens should be removed prior to the instillation of VUITY.

Wait 10 minutes after dosing before reinserting contact lenses [see Warnings and Precautions ( 5.4 )] . Avoiding Contamination of the Product Do not touch dropper tip to any surface, as this may contaminate the contents [see Warnings and Precautions ( 5.5 )] . Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Distributed by: Allergan, an AbbVie company Manufactured for: AbbVie Inc. North Chicago, IL 60064 USA © 2023 AbbVie. All rights reserved.

VUITY and its design are trademarks of Allergan Sales, LLC, an AbbVie company. v5.0USPI7098 Allergan

🧬 Pharmacokinetics 195 words ▾

12.3Pharmacokinetics Systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of VUITY in each eye once daily for 30 days (GEMINI 1). The mean (SD) C max and AUC values from time 0 to last measurable concentration over 10-hour period post-last dose on Day 30 were 1.95 (0.98) ng/mL and 4.14 (2.16) ng·hr/mL, respectively. The median T max value on Day 30 was 0.3 hours postdose with a range from 0.2 to 0.5 hours postdose.

Systemic exposure to pilocarpine was also evaluated in 8 participants with presbyopia who were administered 1 drop of VUITY in each eye twice daily for 14 days (VIRGO). The Day 14 mean (SD) C max following first daily dosing was 1.81 (0.51) ng/mL and following second daily dosing was 2.12 (1.75) ng/mL. The Day 14 mean (SD) AUC over 6-hour post-dose following first daily dose was 4.35 (1.50) ng·hr/mL and following second daily dose was 4.22 (3.14) ng·hr/mL.

There was no significant systemic drug accumulation over time, with accumulation index ratios between Day 1 and Day 14 based on AUC as 1.42 and 1.03 for the first and second daily dose, respectively.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of VUITY dosed once daily for the treatment of presbyopia was demonstrated in two 30‐Day Phase 3, randomized, double‐masked, vehicle‐controlled studies, namely GEMINI 1 (NCT03804268) and GEMINI 2 (NCT03857542). A total of 750 participants aged 40 to 55 years old with presbyopia were randomized (375 to VUITY group) in two studies and participants were instructed to administer one drop of VUITY or vehicle once daily in each eye. In both studies, the proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA), without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) with the same refractive correction was statistically significantly greater in the VUITY group compared to the vehicle group at Day 30, Hour 3 (see Table 1 ).

Table 1: Primary Efficacy Results from GEMINI 1 and GEMINI 2 Studies (Intent-to-Treat Population) GEMINI 1 GEMINI 2 VUITY N=163 Vehicle N=160 p-value VUITY N=212 Vehicle N=215 p-value Proportion of participants gaining 3-lines or more in mesopic DCNVA, without losing more than 1 line (5 letters) of CDVA at Day 30, Hour 3 31% 8% p<0.01 26% 11% p<0.01 Figures 1 and 2 present the proportion of participants who gained 3-lines or more in mesopic DCNVA at Day 30. Figure 1: Proportion of Participants Achieving 3-Lines or More Improvement in Mesopic, High Contrast, Binocular DCNVA at Day 30 in GEMINI 1 (Intent-to-Treat Population) Timepoint Hour 0 Hour

0.25 Hour

0.5Hour 1 Hour 3 Hour 6 Hour 8 Hour 10 VUITY (%) 4.3 17.7 34.8 41.6 30.7 18.4 10.6

7.5Vehicle (%) 5.9 9.8 9.8 15.7 8.1 8.8 8.5

8.6Difference (95% CI) -1.5 (-6.4, 3.3) 7.9 (0.3, 15.5) 25.0 (16.2, 33.8) 25.9 (16.4, 35.5) 22.5 (14.3, 30.8) 9.7 (2.3, 17.0) 2.1 (-4.4, 8.5) -1.1 (-7.1, 5.0) Figure 2: Proportion of Participants Achieving 3-lines or More Improvement in Mesopic, High Contrast, Binocular DCNVA at Day 30 in GEMINI 2 (Intent-to-Treat P opulation ) Timepoint Hour 0 Hour

0.25 Hour

0.5Hour 1 Hour 3 Hour 6 Hour 8 Hour 10 VUITY (%) 7.8 16.1 32.1 37.3 27.6 16.3 14.5

12.6Vehicle (%) 4.0 6.6 9.6 12.1 10.8 9.9 8.6

8.7Difference (95% CI) 3.8 (-0.9, 8.4) 9.4 (3.2, 15.7) 22.5 (14.7, 30.3) 25.2 (17.0, 33.4) 16.7 (9.1, 24.3) 6.5 (-0.1, 13.1) 5.9 (-0.5, 12.2) 3.8 (-2.3, 10.0) The efficacy of VUITY dosed twice daily for the treatment of presbyopia was also demonstrated in a 14-Day, randomized, double-masked, vehicle-controlled study, namely VIRGO (NCT04983589). A total of 230 participants aged 40 to 55 years old with presbyopia were randomized (114 to VUITY group) and participants were instructed to administer one drop of VUITY or vehicle twice daily in each eye, with each dose administered 6 hours apart.

In this study, the proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA), without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) with the same refractive correction was statistically significantly greater in the VUITY group compared to the vehicle group at Day 14, Hour 9 (3 hours after the second dose) (see Table 2 ). Table 2: Primary Efficacy Results from VIRGO (Intent-to-Treat Population) VIRGO VUITY BID N=114 Vehicle BID N=116 p-value Proportion of participants gaining 3-lines or more in mesopic DCNVA, without losing more than 1 line (5 letters) of CDVA at Day 14, Hour 9 (3 hours after the second dose) 35% 8% p<

0.01Figure 3 presents the proportion of participants who gained 3-lines or more in mesopic DCNVA at Day 14. Figure 3 : Proportion of Participants Achieving 3-lines or More Improvement in Mesopic, High Contrast, Binocular DCNVA at Day 14 in VIRGO (Intent-to-Treat Population) Timepoint Hour 0 Hour 1 Hour 3 Hour 6 Hour 7 Hour 9 VUITY BID (%) 12.3 53.5 37.7 27.2 54.4

36.8Vehicle BID (%) 3.4 8.6 7.8 4.3 6.0

8.6Difference (95% CI) 8.8 (2.0, 15.7) 44.9 (34.4, 55.4) 30.0 (19.8, 40.1) 22.9 (13.9, 31.8) 48.4 (38.2, 58… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Pilocarpine did not induce tumors in mice at any dosage level studied (up to 30 mg/kg/day; approximately 80-times the MHOD). In rats, an oral dose of 18 mg/kg/day (approximately 100 times the MHOD), resulted in a statistically significant increase in the incidence of benign pheochromocytomas in both male and female rats, and a statistically significant increase in the incidence of hepatocellular adenomas in female rats. Mutagenesis Pilocarpine did not show any potential to cause genetic toxicity in a series of studies that included: 1) bacterial assays (Salmonella and E. coli) for reverse gene mutations; 2) an in vitro chromosome aberration assay in a Chinese hamster ovary cell line; 3) an in vivo chromosome aberration assay (micronucleus test) in mice; and 4) a primary DNA damage assay (unscheduled DNA synthesis) in rat hepatocyte primary cultures.

Impairment of Fertility Pilocarpine oral administration to male and female rats at a dosage of 18 mg/kg/day (100 times the MHOD) resulted in impaired reproductive function, including reduced fertility, decreased sperm motility, and morphologic evidence of abnormal sperm. It is unclear whether the reduction in fertility was due to effects on males, females, or both. In dogs, exposure to pilocarpine at a dosage of 3 mg/kg/day for 6 months resulted in evidence of impaired spermatogenesis (approximately 55 times the MHOD).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Pilocarpine did not induce tumors in mice at any dosage level studied (up to 30 mg/kg/day; approximately 80-times the MHOD). In rats, an oral dose of 18 mg/kg/day (approximately 100 times the MHOD), resulted in a statistically significant increase in the incidence of benign pheochromocytomas in both male and female rats, and a statistically significant increase in the incidence of hepatocellular adenomas in female rats. Mutagenesis Pilocarpine did not show any potential to cause genetic toxicity in a series of studies that included: 1) bacterial assays (Salmonella and E. coli) for reverse gene mutations; 2) an in vitro chromosome aberration assay in a Chinese hamster ovary cell line; 3) an in vivo chromosome aberration assay (micronucleus test) in mice; and 4) a primary DNA damage assay (unscheduled DNA synthesis) in rat hepatocyte primary cultures.

Impairment of Fertility Pilocarpine oral administration to male and female rats at a dosage of 18 mg/kg/day (100 times the MHOD) resulted in impaired reproductive function, including reduced fertility, decreased sperm motility, and morphologic evidence of abnormal sperm. It is unclear whether the reduction in fertility was due to effects on males, females, or both. In dogs, exposure to pilocarpine at a dosage of 3 mg/kg/day for 6 months resulted in evidence of impaired spermatogenesis (approximately 55 times the MHOD).

📄 Recent Major Changes 27 words ▾

Warnings and Precautions, Blurred Vision ( 5.1 ) 8/2022 Warnings and Precautions, Risk of Retinal Detachment ( 5.2 ) 8/2022 Dosage and Administration ( 2 ) 3/2023

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL NDC 0074-7098-01 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan ™ An AbbVie company NDC 0074-7098-01 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan™ An AbbVie company

PRINCIPAL DISPLAY PANEL NDC 0074-7098-03 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Contains three 2.5 mL bottles Rx Only Sterile For topical application in the eye 3 x 2.5 mL Allergan ™ An AbbVie company NDC 0074-7098-03 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains three 2.5 mL bottles Rx Only Sterile For topical application in the eye 3 x 2.5 mL Allergan™ An AbbVie company

PRINCIPAL DISPLAY PANEL NDC 0074-7098-04 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 2.5 mL For Topical Application in the Eye Allergan ™ An AbbVie company NDC 0074-7098-04 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 2.5 mL For Topical Application in the Eye Allergan™ An AbbVie company

PRINCIPAL DISPLAY PANEL NDC 0074-7098-05 Professional Sample Not for Resale Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 1.5 mL For Topical Application in the Eye Allergan ™ An AbbVie company NDC 0074-7098-05 Professional Sample Not for Resale Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 1.5 mL For Topical Application in the Eye Allergan™ An AbbVie company

PRINCIPAL DISPLAY PANEL NDC: 0074-7098-06 Vuity ® (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 5 mL For Topical Application in the Eye Allergan ™ An AbbVie company NDC: 0074-7098-06 Vuity® (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 5 mL For Topical Application in the Eye Allergan™ An AbbVie company

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle00074-7098-04 487 Rx · $46,429
1 bottle00074-7098-06 256 Rx · $32,182
1 bottle00074-7098-01 No Medicaid data
3 bottles this page00074-7098-03 No Medicaid data
1 bottle00074-7098-05 No Medicaid data
Drug total (last 4 qtrs): 743 Rx · 2,703 units · $78,610 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Vuity — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Vuity. 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
$12.7K
Claims incl. refills
115
Beneficiaries
80
Spend / beneficiary
$158.74
Spend / claim
$110.43
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for VUITY (this brand).

Top reported reactions

Headache311
Visual Impairment185
Vision Blurred175
Eye Pain154
Eye Irritation130
Nausea110
Dizziness102

Age at onset

Adolescent2
Adult143
Elderly142

Reporter sex

2,040 reports
Male · 27%
Female · 73%

Serious outcomes

Hospitalization271
Life-threatening23
Disabling20
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 214 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 1 bottle (00074-7098-01), 1 bottle (00074-7098-04), 1 bottle (00074-7098-05). 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?
AbbVie 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.
← 00074-7096-04 · AbbVie 00074-7148-11 · AbbVie →
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.