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Sodium Chloride 9 mg/mL Injection, Solution — NDC 65282-1510-1 (Billing 65282-1510-01)

by Spectra Medical Deviecs, LLC · 5 TRAY in 1 CARTON / 5 AMPULE in 1 TRAY / 10 mL in 1 AMPULE

This is a package of Sodium Chloride 9 mg/mL Injection, Solution from Spectra Medical Deviecs, LLC, marketed since Jul 2017 and currently FDA-listed. It is this product's only package size.

NDC 65282-1510-01
🏷️ FDA NDC (as labeled) 65282-1510-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🚨
Active recall for this product.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0531-2026
Lots / codes: All lots within expiry · reported Apr 22, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 17, 2026 — Presence of particulate matter: Particulates identified as fiberglass (Baxter Healthcare Corporation) · FDA recall D-0849-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0424-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0432-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0426-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0428-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65282-1510-1
Product NDC 65282-1510
11-digit billing NDC 65282151001
RxCUI 1807637, 1807646
UNII 451W47IQ8X
Application # ANDA206171
SPL Set ID 7e316d21-d6ad-4976-bd90-268fd7e51361
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-07-21
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1807637
Why two NDCs? The FDA registers this code as 65282-1510-1 — a 5-4-1 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 package segment → 65282-1510-01. 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 Sodium class.

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

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. IV forms replace fluid and salt, while injection diluents dissolve other drugs. Other forms are used for rinsing, nasal congestion and nasal care, or to...
  • Follow the directions on your product. Many are used as often as needed by adults and children 4 and over. Do not share the bottle, because that can spread infection.
  • Some people get fever, irritation or infection at the IV site, or too much fluid in the body. Tell your nurse right away if the IV site hurts or looks red.
  • What side effects should I expect with IV sodium chloride?
📖 Read our full Sodium Chloride guide →
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.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65282-1510-01 You're viewing this Main listing 5 TRAY in 1 CARTON / 5 AMPULE in 1 TRAY / 10 mL in 1 AMPULE 2017-07-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bacteriostatic Sodium Chloride 9 mg/mL 00409-1966-05 Hospira, 25 vials $0.067 AP Availability likely —
Sodium Chloride 9 mg/mL 00409-4888-10 Hospira, 25 vials $0.089 AP Availability likely —
Sodium Chloride 9 mg/mL 00264-9375-88 B. 10 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00404-9955-10 Henry 1 vial — — FDA listed —
Sodium Chloride 9 mg/mL 00641-6144-25 Hikma 25 vials — — FDA listed —
Sodium Chloride 9 mg/mL 51662-1342-01 HF 10 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 55154-0126-05 Cardinal 5 vials — AP Discontinued —
Sodium Chloride 9 mg/mL 55154-9357-05 Cardinal 5 vials — — FDA listed —
Sodium Chloride 9 mg/mL 63323-0186-02 Fresenius 25 vials — — FDA listed —
Sodium Chloride 9 mg/mLthis 65282-1510-01 Spectra 5 ampules — AP FDA listed —
Sodium Chloride 9 mg/mL 76420-0083-10 Asclemed 10 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 84549-0888-10 ProPharma 10 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 71872-7248-01 Medical 1 vial — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 71872-7083-01 Medical 1 vial — AP FDA listed —
Sodium Chloride 9 mg/mL 00641-0497-25 Hikma 25 vials — — FDA listed —
Sodium Chloride 9 mg/mL 51662-1464-01 HF 20 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00404-9954-20 Henry 1 vial — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 00404-9953-10 Henry 1 vial — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 63323-0924-10 Fresenius 25 vials — AP FDA listed —
sodium chloride 9 mg/mL 64253-0202-30 Medefil, 60 syringes — — FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 84549-0966-07 ProPharma 30 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65282-1505-01 Spectra 5 ampules — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerSpectra Medical Deviecs, LLC
Application holderSPECTRA MEDICAL DEVICES INC
FDA applicationANDA206171 (ANDA)
Labeler code65282
First marketedJul 2017
Product typeHuman Prescription Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

INDICATION AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

⏱️ Dosage and Administration 57 words ▾

DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

🤒 Adverse Reactions 75 words ▾

ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

🆘 Overdosage 52 words ▾

OVERDOSAGE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS .

🧬 Clinical Pharmacology 185 words ▾

CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The distribution and excretion of sodium (Na ) and chloride (Cl ) are largely under the control of the kidney which maintains a balance between intake and output.

The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 87 words ▾

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Size Container NDC 5 mL Glass ampules packed in carton of 25 each 65282-1505-1 10 mL Glass ampules packed in carton of 25 each 65282-1510-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Spectra Medical Devices, LLC Wilmington, MA 01887 (978) 657-0889 By: Huons Co., Ltd. 100 Bio valley-ro Jecheon-si Chungcheongbuk-do, 27159 Republic of Korea XX#### Rev. # MM/YY

📋 Description 140 words ▾

DESCRIPTION This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg.

It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives.

The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. The glass ampules made up of Type I glass are used as a primary container for the drug product.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Pregnancy Category C Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP.

It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations.

In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.

Use aseptic technique for single or multiple entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers, discard unused portion.

📄 Package Label / Principal Display Panel ~2 min read ▾

Principal Display Panel - 5 mL Carton Label Rx only 25 Single-dose ampules Each single-dose ampule contains 5 mL NDC 65282-1505-1 0.9% Sodium Chloride Injection, USP Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0.

0.308 mOsmol/mL. FOR USE AS A STERILE DILUENT Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature], PRESERVATIVE-FREE To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, LLC.

WILMINGTON, MA. 01887 BY: HUONS. CO., LTD.

Jecheon, Korea 27159 sodium_5_case

Principal Display Panel - 5 mL Ampule Label NDC 65282-1505-1 5 mL Ampule 0.9% Sodium Chloride Injection, USP 0.308 mOsmol/mL (calc) Rx only Single-dose FOR USE AS A STERILE DILUENT PRESERVATIVE-FREE Each mL contains sodium chloride, 9 mg. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0.

MANUFACTURED FOR: Spectra Medical Devices, LLC. Wilmington, MA 01887 By: Huons. Co., Ltd.

Jecheon, Korea 27159 To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. LOT No.: XXX000 EXP.: YYYY/MM sodium_5_label

Principal Display Panel - 10 mL Carton Label Rx only 25 Single-dose ampules Each single-dose ampule contains 10 mL NDC 65282-1510-1 0.9% Sodium Chloride Injection, USP Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0.

0.308 mOsmol/mL (calc). FOR USE AS A STERILE DILUENT For additional information, see package insert. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

PRESERVATIVE-FREE To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, LLC. WILMINGTON, MA.01887 BY : HUONS CO., LTD.

Jecheon, Korea 27159 sodium_10_case

Principal Display Panel - 10 mL Ampule Label NDC 62582-1510-1 10 mL Ampule 0.9 % Sodium Chloride Injection, USP 0.308 mOsmol/mL (calc) Rx only Single-dose FOR USE AS A STERILE DILUENT PRESERVATIVE-FREE Each mL contains sodium chloride, 9 mg. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0.

MANUFACTURED FOR: Spectra Medical Devices, LLC Wilmington, MA 01887 By: Huons Co., Ltd. Jecheon, Korea 27159 To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

LOT No.: XX0000 EXP.: YYYY/MM sodium_10_label

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

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

Medicare Part D (outpatient prescription) spending for Sodium Chloride — the program that covers self-administered drugs. 9 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 Sodium Chloride. 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
$2.42M
Claims incl. refills
105K
Beneficiaries
50.3K
Spend / beneficiary
$48.15
Spend / claim
$23.08
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — 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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Spectra Medical Deviecs, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Spectra Medical Deviecs, LLC 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.
← 65282-1505-01 · Spectra 65282-1605-01 · Spectra →
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.