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Paremyd Hydroxyamphetamine hydrobromide, tropicamide 10; 2.5 mg/mL; mg/mL Solution

by Akorn · 1 BOTTLE, DROPPER in 1 CARTON (17478-704-12) / 15 mL in 1 BOTTLE, DROPPER
NDC 17478-0704-12
🏷️ FDA NDC (as labeled) 17478-704-12 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 17478-704-12
Product NDC 17478-704
11-digit billing NDC 17478070412
NCPDP billing unit ML — per mL (volume)
Application # NDA019261
SPL Set ID da8a8a19-ac1b-4160-aac4-c4c57598eb5d
Mechanism of action Adrenergic Agonists [MoA], Adrenergic Receptor Agonist [EPC], Anticholinergic [EPC], Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route OPHTHALMIC
Dosage form SOLUTION
Substance HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE
GCN Seq No 020045
GCN 69360
HICL code 008190
Ingredient (HICL) Hydroxyamphetamine/Tropicamide
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6J
Therapeutic class — specific (HIC3) Mydriatics
AHFS code 52:24.00.00
AHFS class Mydriatics
FDB label name PAREMYD EYE DROPS
FDB brand name Paremyd
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 17478-704-12 — 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 → 17478-0704-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAkorn
Application holderEPIC PHARMA LLC
FDA applicationNDA019261 (NDA)
Labeler code17478
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PAREMYD EYE DROPS Ingredient Hydroxyamphetamine/Tropicamide

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price 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.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Paremyd 10; 2.5 mg/mL; mg/mLthis 17478-0704-12 Akorn 1 bottle — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
17478-0704-12 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (17478-704-12) / 15 mL in 1 BOTTLE, DROPPER 1992-01-30 Inactivated by FDA

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 17478-704-12, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 17478-0704-12, written without dashes as 17478070412. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 17478-0704-12, the first segment (17478) is the labeler code FDA assigned to Akorn; the middle segment (0704) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Akorn is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 30 words ▾

INDICATIONS PAREMYD ® Solution is indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired. PAREMYD ® provides clinically significant mydriasis with partial cycloplegia.

⏱️ Dosage and Administration 68 words ▾

DOSAGE AND ADMINISTRATION One to two drops in the conjunctival sac. The onset of action with PAREMYD ® Solution occurs within 15 minutes followed by maximum effect within 60 minutes. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours. Mydriasis will reverse spontaneously with time, typically in 6 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.

⛔ Contraindications 47 words ▾

CONTRAINDICATIONS PAREMYD ® Solution should not be used in patients with angle-closure glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of angle-closure glaucoma. This product is also contraindicated in patients who are hypersensitive to any of its components.

⚠️ Warnings 63 words ▾

WARNINGS For topical ophthalmic use only; not for injection. There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma. This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children or the aged. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse have been reported with the use of anticholinergic drugs.

🤒 Adverse Reactions 105 words ▾

ADVERSE REACTIONS Increased intraocular pressure has been reported following use of mydriatics. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, allergic reactions, nausea, vomiting, pallor and muscle rigidity have been reported with the use of tropicamide and/or hydroxyamphetamine hydrobromide, and thus may occur with PAREMYD ® Solution. Central nervous system disturbances have also been reported.

Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs. Rare but serious cardiovascular events, including death due to myocardial infarction, ventricular fibrillation and significant hypotensive episodes have occurred shortly following PAREMYD ® instillation.

🤰 Pregnancy 51 words ▾

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with PAREMYD ® . It is also not known whether PAREMYD ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. PAREMYD ® should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 61 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established. PAREMYD ® may rarely cause CNS disturbances which may be dangerous in infants and children. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs. (See WARNINGS ). Keep this and all medications out of the reach of children.

🧓 Geriatric Use 17 words ▾

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🆘 Overdosage 42 words ▾

OVERDOSAGE Ocular overdosage will cause dilation of the pupils. Systemic overdosage or ingestion of large doses may result in hypertension, cardiac arrhythmias, sub-sternal discomfort, headache, sweating, nausea, vomiting and gastrointestinal irritation. Patients with systemic overdosage should be carefully monitored and treated symptomatically.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY PAREMYD ® Solution combines the effects of the adrenergic agent, hydroxyamphetamine hydrobromide, and the anticholinergic agent, tropicamide. Hydroxyamphetamine hydrobromide is an indirectly-acting sympathomimetic agent which, when applied topically to the eye, causes the release of endogenous norepinephrine from intact adrenergic nerve terminals resulting in mydriasis. Since hydroxyamphetamine hydrobromide has little or no direct activity on the receptor site, dilation does not usually occur if there is damage to the presynaptic nerve terminal, e.g., Horner's Syndrome.

However, it is not known whether damage to the presynaptic nerve terminal will influence the extent of mydriasis produced by PAREMYD ® . Hydroxyamphetamine hydrobromide has minimal cycloplegic action. Tropicamide is a parasympatholytic agent which, when applied topically to the eye, blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.

Tropicamide produces short-duration mydriasis. Although cycloplegia occurs with higher doses of tropicamide, there is evidence with 0.25% tropicamide that full cycloplegia does not occur. Since both these agents act on different effector sites, their simultaneous use produces an additive mydriatic effect.

PAREMYD ® provides diminished pupil responsiveness to light, facilitating ophthalmoscopy. The onset of action with PAREMYD ® occurs within 15 minutes, followed by maximum effect within 60 minutes after instillation of one drop. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours, with recovery beginning at approximately 90 minutes and with complete recovery occurring in most patients in 6 to 8 hours.

However, in some cases complete recovery may take up to 24 hours. Effectiveness may differ slightly in patients with light and dark irides, with those patients with light irides experiencing a slightly greater mydriasis.

📦 How Supplied / Storage and Handling 60 words ▾

HOW SUPPLIED PAREMYD ® (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% as a 15 mL solution in a 15 mL opaque white, low density polyethylene bottle with a natural low density polyethylene dropper tip and a red polypropylene cap. 15 mL - NDC 17478-704-12 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Note: Protect from light.

📦 Storage and Handling 18 words ▾

STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Note: Protect from light.

📋 Description 77 words ▾

DESCRIPTION PAREMYD ® sterile ophthalmic solution is a topical mydriatic combination product for ophthalmic use. STRUCTURAL FORMULAE CHEMICAL NAME Hydroxyamphetamine hydrobromide: Phenol, 4-(2-aminopropyl)-, hydrobromide Tropicamide: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)- CONTAINS Actives: Hydroxyamphetamine hydrobromide, USP.......................1.0% Tropicamide, USP.................................................................0.25% Preservative: Benzalkonium Chloride 0.005% Inactives: Edetate Disodium 0.015%, Sodium Chloride; Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.2 to 5.8 during its shelf life), and Water for Injecton.

The osmolality of PAREMYD ® is approximately 307 mOsm/l. Chemical Structure

💬 Information for Patients 85 words ▾

Information for Patients Patients should be advised not to touch the dropper tip to any surface since this may contaminate the solution. Patients should be advised to use caution when driving or engaging in other hazardous activities while pupils are dilated. Patients may experience photophobia and/or blurred vision and should protect their eyes in bright illumination when pupils are dilated.

Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 17445-6034-00 · Sigma-Aldrich 17504-0007-02 · Lonza →
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.