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Corvatrol 0.9% SODIUM CHLORIDE 9 mg/mL Injection — NDC 70529-0049-40 package photo

Corvatrol 0.9% SODIUM CHLORIDE 9 mg/mL Injection

by IT3 Medical LLC · 4 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-40) / 30 mL in 1 VIAL, MULTI-DOSE
NDC 70529-0049-40
🏷️ FDA NDC (as labeled) 70529-049-40 billing pads the product segment with a zero
This package
Contains30 mL in 1 vial, multi-dose Pack sizes8 compare ↓
Also comes in: 30 mL 70529-0049-01 10 mL 70529-0049-15 2 vials 70529-0049-20 2 vials 70529-0049-25 3 vials 70529-0049-30 3 vials 70529-0049-35 4 vials 70529-0049-45
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 16, 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

⚠️
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 II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0433-2026
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-0425-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0429-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0431-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
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) 70529-049-40
Product NDC 70529-049
11-digit billing NDC 70529004940
Application # ANDA088911
SPL Set ID b344c76d-5ba1-4e1e-9560-deda154e43fe
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Dosage form INJECTION
Substance SODIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 70529-049-40 — 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 → 70529-0049-40. 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

LabelerIT3 Medical LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA088911 (ANDA)
Labeler code70529
Product typeHuman Prescription Drug
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

📗 Our plain-language guide HelloPharmacist
  • Yes, exactly. Saline is just sodium chloride dissolved in water — it's essentially a sterile salt-water solution. Depending on the concentration and form, it can be used as an IV f...
  • I've heard of saline solution — is that the same thing as sodium chloride?
  • In some situations — like after surgery, during serious illness, or when someone can't take anything by mouth — the body needs fluids and electrolytes delivered directly into the b...
  • Why would someone need sodium chloride through an IV? Can't you just drink water?
📖 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.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid 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 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.

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

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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 mL 10 mL 2 vials 2 vials 3 vials 3 vials 4 vials
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
Corvatrol 0.9% 9 mg/mLthis 70529-0049-40 IT3 4 vials — AP Discontinued —
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

📍
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.

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

Medicare Part D (outpatient prescription) spending for Sodium Chloride (matched by generic name) — the program that covers self-administered drugs. 2 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
$16.2K
Claims incl. refills
266
Beneficiaries
53
Spend / beneficiary
$304.99
Spend / claim
$60.77
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70529-0049-01 1 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-01) / 30 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA
70529-0049-15 1 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-15) / 10 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA
70529-0049-20 2 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-20) / 30 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA
70529-0049-25 2 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-25) / 10 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA
70529-0049-30 3 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-30) / 30 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA
70529-0049-35 3 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-35) / 10 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA
70529-0049-40 You're viewing this 4 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-40) / 30 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA
70529-0049-45 4 VIAL, MULTI-DOSE in 1 PACKAGE (70529-049-45) / 10 mL in 1 VIAL, MULTI-DOSE 2017-03-01 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 70529-0049-40?
NDC 70529-0049-40 is listed by the FDA — 4 vial, multi-dose in 1 package / 30 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Corvatrol 0.9% SODIUM CHLORIDE 9 mg/mL Injection?
Bill NDC 70529-0049-40 — the 11-digit billing format is 70529004940. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70529-049-40, 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: 70529-0049-40, written without dashes as 70529004940. 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 70529-0049-40, the first segment (70529) is the labeler code FDA assigned to IT3 Medical LLC; the middle segment (0049) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 1 vial (70529-0049-01), 1 vial (70529-0049-15), 2 vials (70529-0049-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
IT3 Medical 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.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 36 words ▾

INDICATIONS AND USAGE These parenteral preparations are 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. NOT FOR INHALATION .

⏱️ Dosage and Administration 133 words ▾

DOSAGE AND ADMINISTRATION NOT FOR INHALATION . Before Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride or benzyl alcohol. 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.

Isotonic solutions may be given subcutaneously, intravenously, and occasionally, intramuscularly. Use Bacteriostatic Sodium Chloride Injection, USP, 0.9% with due regard for the compatibility of the benzyl alcohol it contains with the particular medicinal substance that is to be dissolved or diluted. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS Due to potential toxicity of benzyl alcohol in newborns, Bacteriostatic Sodium Chloride Injection, USP, 0.9% containing benzyl alcohol must not be used in this patient population. Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for fluid or sodium chloride replacement.

⚠️ Warnings 72 words ▾

WARNINGS Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection, USP, 0.9% has been associated with toxicity in newborns. Data is unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection, USP, 0.9% should be used for flushing intravascular catheters.

Where a sodium chloride solution is required for preparing or diluting medications for use in newborns, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.

🤒 Adverse Reactions 155 words ▾

ADVERSE REACTIONS Reactions which may occur because of Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 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.

Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg infant is potentially capable of producing blood pressure changes.

🆘 Overdosage 49 words ▾

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

🧬 Clinical Pharmacology 191 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 Bacteriostatic Sodium Chloride Injection, USP, 0.9%, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in 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 to 1.5 liters each of 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 161 words ▾

HOW SUPPLIED Bacteriostatic Sodium Chloride Injection, USP, 0.9%, preserved with benzyl alcohol is available as follows: NDC No. Strength 70529-049-01 0.9% 30 mL multiple dose plastic vial, in a package. 70529-049-20 0.9% Two 30 mL multiple dose plastic vials, in a package.

70529-049-30 0.9% Three 30 mL multiple dose plastic vials, in a package. 70529-049-40 0.9% Four 30 mL multiple dose plastic vials, in a package. 70529-049-15 0.9% 10 mL multiple dose plastic vial, in a package.

70529-049-25 0.9% Two 10 mL multiple dose plastic vials, in a package. 70529-049-35 0.9% Three 10 mL multiple dose plastic vials, in a package. 70529-049-45 0.9% Four 10 mL multiple dose plastic vials, in a package.

Use only if solution is clear and seal intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 45765D Revised: April 2008 Assembled and Distributed by IT3 Medical, LLC 190 E Stacy Road; STE 306-298, Allen, TX 75002-8734 For questions or comments: [email protected], www.IT3-Medical.com

📋 Description 88 words ▾

DESCRIPTION Bacteriostatic Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic, isotonic solution. Each mL contains: Sodium chloride 9 mg; benzyl alcohol 0.9%; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0).

Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol.

The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70518-4754-00 · REMEDYREPACK 70533-0001-50 · Harry's, →
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.