Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Olopatadine HCl olopatadine hydrochloride 7 mg/mL Solution/ Drops, 1 bottle — NDC 0536-1478-23 (Billing 00536-1478-23)
by Rugby Laboratories · 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER
This is a package of 1 bottle of Olopatadine HCl olopatadine hydrochloride 7 mg/mL Solution/ Drops from Rugby Laboratories, marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.
NDC 00536-1478-23
🏷️ FDA NDC (as labeled)
0536-1478-23
billing pads the labeler segment with a zero
🗂️ FDA directory synced Oct 8, 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 →
NDC database record
One package, one record: these facts belong to NDC 0536-1478-23 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0536 labeler · 1478 product · 23 package
- Package marketed since
- Jan 15, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0536147823 0
- Medicaid fills, this package
- 24 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0536-1478-23
Product NDC
0536-1478
11-digit billing NDC
00536147823
NCPDP billing unit
ML — per mL (volume)
RxCUI
1601086
UNII
2XG66W44KF
Application #
ANDA213514
SPL Set ID
edb068e2-1835-483e-e59c-bcbe13b66d76
Established class (EPC)
Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer
Mechanism of action
Histamine H1 Receptor Antagonists
Physiologic effect
Decreased Histamine Release
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-01-15
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
OLOPATADINE HYDROCHLORIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
86802065102040
GCN Seq No
073483
GCN
37855
HICL code
012815
Ingredient (HICL)
Olopatadine Hcl
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
Q6R
Therapeutic class — specific (HIC3)
Eye Antihistamines
AHFS code
52:02.00.00
AHFS class
Antiallergic Agents
FDB label name
OLOPATADINE HCL 0.7% EYE DROPS
FDB brand name
Olopatadine Hcl
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 073483
- GCN: 37855
- GPI-14 (Medi-Span): 86802065102040
- HICL (First Databank): 012815
- AHFS class code: 52:02.00.00
- RxCUI (RxNorm): 1601086
Why two NDCs?
The FDA registers this code as 0536-1478-23 — 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 → 00536-1478-23. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Inhibitor class.
Pharmacologic class
Histamine-1 Receptor Inhibitor, Histamine-1 Receptor Antagonist, Mast Cell Stabilizer
Drug family (ATC)
Antiallergic agents, excl. corticosteroids, Other antiallergics
How it works
Histamine H1 Receptor Antagonists
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name OLOPATADINE HCL 0.7% EYE DROPS Ingredient Olopatadine Hcl
📗 Our plain-language guide HelloPharmacist
- The eye drops relieve itchy eyes from allergies, and some products relieve redness too. The nasal spray relieves seasonal allergic rhinitis symptoms in adults and children 6 and ol...
- It depends on the product. Some eye drops are twice daily, 6 to 8 hours apart, and others once daily. The nasal spray is twice daily. Follow your label or prescriber.
- Take your lenses out before using the drops and wait at least 10 minutes before putting them back. Don't wear lenses if your eyes are red. These drops aren't for contact lens irrit...
- With the nasal spray, a bitter taste, headache, nosebleeds and sore throat are common. It can also make you drowsy, so be careful driving and skip alcohol.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Olopatadine Hydrochloride — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about olopatadine hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $7.42 | $18.54 / 2.5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00536-1478-23 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER | 2026-01-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pataday Once Daily Relief 7 mg/mL 00065-0816-01 | Alcon | 2 bottles | — | — | FDA listed | — |
| Eye Allergy Itch Relief 7 mg/mL 00363-1325-01 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Olopatadine HCl 7 mg/mLthis 00536-1478-23 | Rugby | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 7 mg/mL 51316-0567-01 | CVS | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Eye Drops 7 mg/mL 51316-0633-02 | CVS | 2 bottles | — | — | FDA listed | — |
| olopatadine hydrochloride ophthalmic 7 mg/mL 68083-0398-01 | Gland | 1 bottle | — | — | FDA listed | — |
| Eye Allergy Itch Relief 7 mg/mL 70000-0746-01 | CARDINAL | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 7 mg/mL 75907-0285-10 | Dr. | 1000 bottles | — | — | FDA listed | — |
| Eye Allergy Itch Relief 7 mg/mL 75907-0343-25 | Dr. | 2 bottles | — | — | FDA listed | — |
| Eye Allergy Itch Relief 7 mg/mL 82442-0027-25 | TARGET | 1 bottle | — | — | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Olopatadine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
-
UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII P6BYU725IU
A modified carbohydrate that acts as a solubilizer and stabilizer in medicines. It helps dissolve poorly water-soluble drugs and protects active ingredients from degradation during storage.
-
UNII RN3152OP35
Hypromellose is a plant-based thickener and film-former derived from cellulose. In medicines, it's used to create coatings on tablets and capsules, control how fast the drug dissolves, and improve the product's texture and stability.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone and purified water.
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerRugby Laboratories
Application holderGLAND PHARMA LTD
FDA applicationANDA213514 (ANDA)
Labeler code00536
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio149 products on file
More NDCs from Rugby Laboratories labeler code 00536
- Rugby Benzoyl Peroxide Acne Medication 100 mg/g Gel NDC 0536-1459-25
- Rugby Benzoyl Peroxide Acne Medication 25 mg/g Gel NDC 0536-1466-25
- Rugby Benzoyl Peroxide Acne Medication 50 mg/g Gel NDC 0536-1467-25
- Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g Lotion NDC 0536-1474-42
- Lubricant Eye Carboxymethylcellulose Sodium 5 mg/mL Solution/ Drops NDC 0536-1476-92
- Rugby Pain Relieving Analgesic Menthol, Unspecified Form and Methyl Salicylate 12.5 mg/g; 150 mg/g Cream NDC 0536-1477-45
- Cough Suppressant Adult Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled NDC 0536-1480-34
- Rugby Antifungal tolnaftate aerosol, powder 10 mg/g Aerosol, Spray NDC 0536-1481-01
- Senna 8.8 mg/5mL Solution NDC 0536-1483-59
- Rugby Mucus Relief ER guaifenesin 600 mg Tablet, Multilayer, Extended Release NDC 0536-1489-20
- Rugby Allergy Relief D fexofenadine hydrochloride, pseudoephedrine hydrochloride 60 mg; 120 mg Tablet, Film Coated, Extended Release NDC 0536-1491-07
- Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasis Salicylic Acid, Sulfur 20 mg/1000mL; 20 mg/1000mL Shampoo NDC 0536-1962-97
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
USE temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
⏱️ Dosage and Administration ▾
DIRECTIONS adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily do not use more than 1 drop in each eye per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: consult a doctor
⚠️ Warnings ▾
WARNINGS For external use only
🧪 Active Ingredient ▾
ACTIVE INGREDIENT Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone and purified water.
🎯 Purpose ▾
PURPOSE Antihistamine
📄 Do Not Use ▾
DO NOT USE • if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation
📄 When Using This Product ▾
WHEN USING THIS PRODUCT • do not touch tip of container to any surface to avoid contamination • remove contact lenses before use • wait at least 10 minutes before reinserting contact lenses after use • do not wear a contact lens if your eye is red
📄 Stop Use and Ask a Doctor If ▾
STOP USE AND ASK DOCTOR IF you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours
📄 Keep Out of Reach of Children ▾
KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).
📄 Other Information ▾
OTHER INFORMATION • only for use in the eye • store between 2° to 25°C (36° to 77°F)
📄 Questions or Comments ▾
QUESTIONS? call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Carton Label: NDC 0536-1478-23 extra strength olopatadine HCl ophthalmic solution USP, 0.7% antihistamine once daily relief eye allergy itch relief works in minutes FULL 24 HR relief from allergens: • pet dander • pollen • grass • ragweed 2.5 mL (0.085 fl oz) sterile Compare to active ingredient in Extra Strength Pataday Once Daily Relief* Tamper Evident: Do not use if seal is damaged or missing at time of purchase. For Ages 2 and Older 30 DAY SUPPLY Bottle Label: extra strength olopatadine HCl ophthalmic solution USP, 0.7% antihistamine once daily relief eye allergy itch relief 2.5 mL (0.085 fl oz) sterile
No label section mentions that — try another word, or open the full label on DailyMed below.
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 2026 – Q1 2026 · 1 quarter 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
24
Units reimbursed last 4 qtrs
93
Gross reimbursed last 4 qtrs
$689.67
Avg / prescription
$28.74
Avg / unit
$7.4559
Latest quarter Q1 2026
24Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 24 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.80.8
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
💵 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.
Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Olopatadine HCl — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Olopatadine HCl. 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
$753.9K
Claims incl. refills
9.5K
Beneficiaries
7.5K
Spend / beneficiary
$99.96
Spend / claim
$79.21
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 Olopatadine HCl (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 33%
Female · 67%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — 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) | ✓ Available |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Rugby Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rugby Laboratories 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
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.