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Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid, 118 mL — NDC 00485-0204-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid, 118 mL — NDC 0485-0204-04 (Billing 00485-0204-04)

by Edwards Pharmaceuticals, Inc · 118 mL in 1 BOTTLE, PLASTIC

This is a package of 118 mL of Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid from Edwards Pharmaceuticals, Inc, marketed since Mar 2011 and currently FDA-listed; retail pharmacies pay about $0.0750 per mL (NADAC).

NDC 00485-0204-04
🏷️ FDA NDC (as labeled) 0485-0204-04 billing pads the labeler segment with a zero
This package
Contains118 mL Cost per mL$0.0750 NADAC Per package$8.85 / 118 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0794/unit — full pricing hub ↓
Product page 00485-0204-16 Also comes in: 473 ml 0485-0204-16
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 0485-0204-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0485 labeler · 0204 product · 04 package
Package marketed since
Mar 14, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
118 mL per package
Barcode (UPC-A, from the NDC)
3 0485020404 6
Medicaid fills, this package
8,289 prescriptions in the last four reported quarters
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0485-0204-04
Product NDC 0485-0204
11-digit billing NDC 00485020404
NCPDP billing unit ML — per mL (volume)
RxCUI 1090463
UNII 04JA59TNSJ, IXA7C9ZN03, 9D2RTI9KYH
Application # M012
SPL Set ID 7be2c282-24ba-4f19-9b14-872d3f5746a7
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-03-14
Route ORAL
Dosage form LIQUID
Substance PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE

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

GPI-14 43995803080910
GPI class Rynex DM
GCN Seq No 060622
GCN 26808
HICL code 035368
Ingredient (HICL) Brompheniram/Phenylephrine/Dm
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3R
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Gen.antihistamine-Decongest
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name RYNEX DM LIQUID
FDB brand name Rynex Dm
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 060622
  • GCN: 26808
  • GPI-14 (Medi-Span): 43995803080910
  • HICL (First Databank): 035368
  • AHFS class code: 04:04.20.00
  • RxCUI (RxNorm): 1090463
Why two NDCs? The FDA registers this code as 0485-0204-04 — 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 → 00485-0204-04. 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 Substituted alkylamines class.

Drug family (ATC) Substituted alkylamines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RYNEX DM LIQUID Ingredient Brompheniram/Phenylephrine/Dm
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Brompheniramine is used to treat allergy and cold symptoms: sneezing runny nose itching of the nose or throat red, itchy, watery eyes Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
🧪 What is this product?

Rynex DM is an oral liquid cold and cough product sold over the counter under FDA's OTC monograph rules. It contains three active ingredients commonly used to relieve symptoms associated with the common cold and upper respiratory conditions. Brompheniramine maleate functions as an antihistamine typically used to reduce sneezing and runny nose. Dextromethorphan hydrobromide is a cough suppressant, and phenylephrine hydrochloride is a nasal decongestant, both commonly included in products meant to ease respiratory discomfort.

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 $0.075 $8.85 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.0794 $9.37 / 118 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.075 $0.016
▲ Up 355% over the last 24 months.
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
00485-0204-04 You're viewing this 118 mL in 1 BOTTLE, PLASTIC $0.0750 / mL $8.85 2011-03-14 — Active
00485-0204-16 0485-0204-16 Main listing 473 mL in 1 BOTTLE $0.0512 / mL $24.22 2011-03-14 — Active

You're viewing the smallest of 2 pack sizes for this product.

Per mL, this pack runs about 46% above the cheapest pack (473 mL, $0.0512 vs $0.0750 NADAC).

This pack accounts for about 17% of this product's recent Medicaid fills; most go to the 473 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle, plastic.
How does this package differ from NDC 00485-0204-16?
Both are Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid — the drug itself is identical. This page's package is the 118 mL one, while NDC 00485-0204-16 is the 473 ml package. Per-mL NADAC also differs: $0.0750 here vs $0.0512 for the 473 ml pack.
What NDC number is used to bill for this package of Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid?
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
Cold and Cough Relief children 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 70677-0121-01 Strategic 1 bottle $0.017 — Discontinued save 77%
EndaCof DM 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 68047-0143-16 Larken 473 ml $0.051 — Availability likely save 32%
Good Sense Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 00113-0987-26 L. 1 bottle $0.075 — Availability likely —
Rynex DM 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mLthis 00485-0204-04 Edwards 118 ml $0.075 — Availability likely —
dimaphen dm 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 00904-6463-20 Major 1 bottle $0.075 — Availability likely —
good neighbor pharmacy cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 24385-0519-26 Amerisource 1 bottle $0.075 — Availability likely —
Signature Care Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 21130-0082-26 Safeway 1 bottle — — Discontinued —
Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 30142-0987-26 Kroger 1 bottle — — FDA listed —
cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 37808-0987-26 H 1 bottle — — FDA listed —
equaline childrens cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 41163-0987-26 United 1 bottle — — FDA listed —
CareOne Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 41520-0987-26 American 1 bottle — — Discontinued —
equate childrens cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 49035-0082-34 Wal-Mart 1 bottle — — FDA listed —
Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 51316-0578-03 CVS 1 bottle — — FDA listed —
Childrens Dimetapp Cold And Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 51316-0645-08 CVS 1 bottle — — FDA listed —
Pediacare Childrens Cough and Cold Grape 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 52412-0920-01 RANDOB 1 bottle — — FDA listed —
Childrens Metapp Daytime 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 53041-0577-03 Guardian 1 bottle — — FDA listed —
Cold and Cough DM 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 56062-0987-26 Publix 1 bottle — — FDA listed —
dimaphen dm 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 68788-8134-01 Preferred 1 bottle — — FDA listed —
Good Sense Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 68788-8331-01 Preferred 1 bottle — — FDA listed —
Dimetapp Cold and Cough 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 80070-0310-04 Foundation 1 bottle — — FDA listed —
TARGET CHILDRENs COLD and COUGH 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 82442-0645-04 TARGET 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
2011
On the market since
Mar 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
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.

What it looks like

FlavorTutti Frutti
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesCitric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerEdwards Pharmaceuticals, Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00485
First marketedMar 2011
Product typeHuman Otc Drug

More NDCs from Edwards Pharmaceuticals, Inc labeler code 00485

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

Uses temporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

⏱️ Dosage and Administration 62 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years of age and older: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours. Children under 6 years of age: Consult a doctor

⚠️ Warnings ~1 min read ▾

Warnings Do not exceed recommended dosage. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating to to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

A persistent cough may be a sign of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 10 words ▾

Other information Store at 59° - 86°F (15° - 30°C)

🧪 Active Ingredient 20 words ▾

Drug Facts Active ingredients (in each 5 mL teaspoonful) Brompheniramine Maleate 1mg Dextromethorphan Hydrobromide 5 mg Phenylephrine Hydrochloride 2.5 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

🎯 Purpose 5 words ▾

Purpose Antihistamine Antitussive Nasal Decongestant

📄 Do Not Use 57 words ▾

Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 58 words ▾

Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating to to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 36 words ▾

When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 49 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions? Comments? Call 1-800-543-9560

📄 Package Label / Principal Display Panel 149 words ▾

PRODUCT PACKAGING The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 00485-0204-16 Rynex DM Liquid ANTIHISTAMINE ∙ ANTITUSSIVE NASAL DECONGESTANT Each 5 mL (one teaspoonful) for oral administration contains: Brompheniramine Maleate, USP..................1 mg Dextromethorphan HBr, USP.......................5 mg Phenylephrine HCl, USP...........................2.5 mg ALCOHOL FREE ∙ DYE FREE GLUTEN FREE ∙ SUGAR FREE ______________________________________________ FOR PROFESSIONAL USE ONLY Tutti-Frutti Flavor Manufactured for: EDWARDS Pharmaceuticals, Inc.

Ripley, MS 38663 16 fl oz (473 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container with a child-resistant cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER. The labeling for this product includes professional labeling which is not intended for use by the general public. Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663 Iss.

01/12 label back insert

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
8.3K
Units reimbursed last 4 qtrs
1.5M
Gross reimbursed last 4 qtrs
$117.2K
Avg / prescription
$14.13
Avg / unit
$0.0794
Latest quarter Q4 2025
2.4KRx
Medicaid pays / mL
$0.0794
gross reimbursed
vs
NADAC / mL
$0.0750
acquisition cost
=
Spread
+$0.0044
+6% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
21% FFS 79% MCO
Fee-for-service · 1,734 Rx Managed care · 6,555 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 33,450 units · 171 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 27,185 units · 293 per 100k residents NJ Massachusetts: no data reported MA California: 204,982 units · 526 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 3,122 units · 69.0 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 1,168,394 units · 39,741 per 100k residents MS Alabama: no data reported AL Georgia: 31,406 units · 285 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 7,753 units · 25.4 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
25.439,741
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Mississippi 39,741 /100k
2 California 526 /100k
3 New Jersey 293 /100k
4 Georgia 285 /100k
5 New York 171 /100k
6 Kentucky 69.0 /100k
7 Texas 25.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
473 ml00485-0204-16 40,578 Rx · $675,192
118 ml this page00485-0204-04 8,289 Rx · $117,164
Drug total (last 4 qtrs): 48,867 Rx · 9,671,079 units · $792,357 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 00485-0202-16 · EDWARDS 00485-0206-16 · EDWARDS →
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.