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Ascorbic Acid 500 mg/mL Injection

by Renova Pharmaceuticals LLC · 1 VIAL, GLASS in 1 CARTON (84897-058-01) / 50 mL in 1 VIAL, GLASS

NDC 84897-0058-01

🏷️ FDA NDC (as labeled) 84897-058-01 billing pads the product segment with a zero

This package

Contains50 mL in 1 vial, glass Pack sizes2 compare ↓

Also comes in: 25 vials 84897-0058-25

Rx only Generic On market Non-controlled

🗂️ Data synced Sep 3, 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 84897-058-01

Product NDC 84897-058

11-digit billing NDC 84897005801

RxCUI 308395

UNII PQ6CK8PD0R

UPC 0384897058017

Application # ANDA220172

SPL Set ID a6481bae-2397-44c7-a51d-4f47ad91bd2c

Established class (EPC) Vitamin C

Chemical class Ascorbic Acid

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-08-08

Route INTRAVENOUS

Dosage form INJECTION

Substance ASCORBIC ACID

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 84897-058-01 — 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 → 84897-0058-01. 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 Vitamin C class.

Pharmacologic class Vitamin C

Drug family (ATC) Ascorbic acid (vitamin C), plain, Organic acids, Other ophthalmologicals

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.

🏭 Manufacturer & labeler

LabelerRenova Pharmaceuticals LLC

Application holderSTIRA PHARMACEUTICALS LLC

FDA applicationANDA220172 (ANDA)

Labeler code84897

First marketedAug 2026

Product typeHuman Prescription Drug

Portfolio4 products on file

🔎 All NDCs from Renova Pharmaceuticals LLC

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

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

0.25 mg / 1 mL UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
130 mg / 1 mL UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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 system	Per each	Per 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: 25 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ascor 500 mg/mL 67157-0101-50	McGuff	1 vial	—	AP	FDA listed	—
Ascorbic Acid 500 mg/mL 65219-0027-50	Fresenius	25 vials	—	AP	FDA listed	—
Ascorbic Acid 500 mg/mLthis 84897-0058-01	Renova	1 vial	—	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

🏛️

2026

On the market since

Aug 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
84897-0058-01 You're viewing this	1 VIAL, GLASS in 1 CARTON (84897-058-01) / 50 mL in 1 VIAL, GLASS	2026-08-08	Active
84897-0058-25	25 VIAL, GLASS in 1 TRAY (84897-058-25) / 50 mL in 1 VIAL, GLASS	2026-08-08	Active

Pack size FAQ

What quantity is in NDC 84897-0058-01?

NDC 84897-0058-01 is listed by the FDA — 1 vial, glass in 1 carton / 50 ml in 1 vial, glass.

What NDC number is used to bill for this package of Ascorbic Acid 500 mg/mL Injection?

Bill NDC 84897-0058-01 — the 11-digit billing format is 84897005801. 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

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.

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 84897-058-01, 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: 84897-0058-01, written without dashes as 84897005801. 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 84897-0058-01, the first segment (84897) is the labeler code FDA assigned to Renova Pharmaceuticals LLC; the middle segment (0058) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Renova Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 25 vials (84897-0058-25). 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?

Renova Pharmaceuticals 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 129 words ▾

1 INDICATIONS AND USAGE Ascorbic Acid Injection is indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients, age 5 months and older, for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use Ascorbic Acid Injection is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. Ascorbic Acid Injection is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Limitations of Use Ascorbic Acid Injection is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Supplied in a Pharmacy Bulk Package (PBP). Dispense single doses to multiple patients in a pharmacy admixture program; use within 4 hours of puncture. (2.1) Must be diluted prior to use (2.1) Administer as a slow intravenous infusion (2.1) See Full Prescribing Information for important administration instructions (2.1) Maximum recommended duration is one week (2.2) Population (2.2) Recommended Doses Pediatric patients age 5 months to less than 12 months 50 mg once daily Pediatric patients age 1 year to less than 11 years 100 mg once daily Adults and pediatric patients age 11 years and older 200 mg once daily Specific Populations (2.3 , 8.1, 8.2 ) Pregnant women, lactating women, patients with glucose-6-phosphate dehydrogenase deficiency Should not exceed the U.S.

Recommended Dietary Allowance (RDA)

2.1Important Preparation and Administration Instructions Ascorbic Acid Injection vials contain 25,000 mg of ascorbic acid and the largest recommended single dose is 200 mg. Do not give the entire contents of the vial to a single patient. Do not administer Ascorbic Acid Injection as an undiluted intravenous injection.

Minimize exposure to light because Ascorbic Acid Injection is light sensitive. Ascorbic Acid Injection is supplied as a Pharmacy Bulk Package (PBP) which is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion: a. Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area). b.

Penetrate each PBP vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. Given that pressure may develop within the vial during storage, excercise caution when withdrawing contents from the vial. c. Once the closure system has been penetrated, complete all dispensing from the PBP vial within 4 hours .

Each dose must be used immediately . Discard unused portion. d. Prior to administration, Ascorbic Acid Injection must be diluted in a suitable infusion solution and the final solution for infusion must be isotonic (undiluted the osmolarity of Ascorbic Acid Injection is approximately 5,900 mOsmol/L).

Prior to preparing the admixture for infusion, calculate the osmolarity of the intended admixture for infusion. Add one daily dose of Ascorbic Acid Injection directly to an appropriate volume of a suitable infusion solution (e.g., 5% Dextrose Injection, Sterile Water for Injection) and add appropriate solutes, as necessary, to make the final solution isotonic. Sterile Water for Injection is highly hypotonic; adjust solute content, as necessary, to make the final infusion solution isotonic prior to injection.

Do not mix Ascorbic Acid Injection with solutions containing elemental compounds that can be reduced (e.g., copper). The concentration of ascorbic acid in the final, admixture solution for infusion is to be in the range of 1 to 25 mg of ascorbic acid per mL. For example, for the largest recommended dose: Add 200 mg of ascorbic acid (equivalent to 0.4 mL of Ascorbic Acid Injection) to 7.5 mL of Sterile Water for Injection to produce an infusion solution having an approximate osmolarity of 290 mOsmol/L.

In this specific example, addition of solute is NOT necessary because the solution is isotonic. e. Prepare the recommended dose based on the patient population [see Dosage and Administration (2.2), (2.3)]. f. Visually inspect for particulate matter and discoloration prior to administration (the diluted Ascorbic Acid Injection solution should appear colorless to pale yellow). g.

Immediately administer the admixture for infusion as a slow intravenous infusion [see Recommended Dosage (2.2)].

2.2Recommended Dosage Table 1 provides recommended doses of Ascorbic Acid Injection based on patient population and infusion rates of diluted Ascorbic Acid Injection solution. Table 1: Recommended…

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 25,000 mg/50 mL (500 mg/mL) supplied as a Pharmacy Bulk Package (clear, colorless to pale yellow solution) Injection: 25,000 mg /50 mL (500 mg/mL)-Pharmacy Bulk Package

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None None

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Oxalate nephropathy and Nephrolithiasis: Ascorbic acid has been associated with development of acute or chronic oxalate nephropathy following prolonged use of high doses of ascorbic acid infusion. Patients with renal disease including renal impairment, history of oxalate kidney stones, geriatric patients, and pediatric patients less than 2 years old may be at increased risk ( 5.1 ). Hemolysis : Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced dose is recommended ( 5.2 ).

Laboratory Test Interference: Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing ( 5.3 ).

5.1Oxalate Nephropathy and Nephrolithiasis Acute and chronic oxalate nephropathy have been reported with prolonged administration of high doses of ascorbic acid. Acidification of the urine by ascorbic acid may cause precipitation of cysteine, urate or oxalate stones. Patients with renal disease including renal impairment, history of oxalate kidney stones, and geriatric patients may be at increased risk for oxalate nephropathy while receiving treatment with ascorbic acid.

Pediatric patients less than 2 years of age may be at increased risk for oxalate nephropathy during treatment with ascorbic acid because their kidneys are immature [see Use in Specific Populations ( 8.4, 8.5, 8.6 )]. Monitor renal function in patients at increased risk receiving Ascorbic Acid Injection. Discontinue Ascorbic Acid Injection in patients who develop oxalate nephropathy and treat any suspected oxalate nephropathy.

Ascorbic Acid Injection is not indicated for prolonged administration (the maximum recommended duration is one week) [see Dosage and Administration ( 2.1 )] .

5.2Hemolysis in Patients with Glucose-6-Phosphate Dehydrogenase Deficiency Hemolysis has been reported with administration of ascorbic acid in patients with glucose-6-phosphate dehydrogenase deficiency. Patients with glucose-6-phosphate dehydrogenase deficiency may be at increased risk for severe hemolysis during treatment with ascorbic acid. Monitor hemoglobin and blood count and use a reduced dose of Ascorbic Acid Injection in patients with glucose-6-phosphate dehydrogenase deficiency [see Dosage and Administration (2.3) ].

Discontinue treatment with Ascorbic Acid Injection if hemolysis is suspected and treat as needed.

5.3Laboratory Test Interference Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing, nitrite and bilirubin levels, and leucocyte count testing. If possible, laboratory tests based on oxidation-reduction reactions should be delayed until 24 hours after infusion of Ascorbic Acid Injection [see Drug Interactions ( 7.4 )].

Ascorbic Acid Injection is not indicated for prolonged administration (the maximum recommended duration is one week) [see Dosage and Administration ( 2.1 )] .

5.2Hemolysis in Patients with Glucose-6-Phosphate Dehydrogenase Deficiency Hemolysis has been reported wi…

🤒 Adverse Reactions ~1 min read ▾

6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Oxalate nephropathy and Nephrolithiasis [see Warnings and Precautions ( 5.1 )]. Hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency [see Warnings and Precautions ( 5.2 )].

The following adverse reactions associated with the use of ascorbic acid were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Administration site reactions : pain and swelling. Ascorbic Acid Injection should not be rapidly administered.

Rapid intravenous administration (>250 mg/minute) of Ascorbic Acid Injection may cause temporary faintness or nausea, lethargy, flushing, dizziness, and headache (the recommended infusion rates of diluted Ascorbic Acid Injection solution are 1.3 mg/minute (Pediatric Patients age 5 months to less than 12 months), 3.3 mg/minute (Pediatric Patients age 1 year to less than 11 years) and 33 mg/minute (Adults and Pediatric Patients 11 years and older) [see Dosage and Administration ( 2.2 )]) . Acute and chronic oxalate nephropathy have occurred with prolonged administration of high doses of ascorbic acid [see Warnings and Precautions ( 5.1 )].

In patients with glucose-6-phosphate dehydrogenase deficiency, severe hemolysis has occurred [see Warnings and Precautions ( 5.2 )]. Most common adverse reactions are pain and swelling at the site of infusion (6) To report SUSPECTED ADVERSE REACTIONS, contact Renova Pharmaceuticals LLC. at 1-888-211-5593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~3 min read ▾

7. DRUG INTERACTIONS Antibiotics : Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid (7.1) . Amphetamine and Other Drugs Affected by Urine Acidification : Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels and affect excretion and plasma concentrations of other drugs sensitive to urine pH (7.2) . Warfarin: Continue standard monitoring (7.3) .

7.1Antibiotics Ascorbic acid may decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid. If the antibiotic efficacy is suspected to be decreased by concomitant administration of Ascorbic Acid Injection, discontinue Ascorbic Acid Injection administration.

7.2Amphetamine & Other Drugs Affected by Urine Acidification Ascorbic acid may acidify the urine and lower serum concentrations of amphetamine by increasing renal excretion (as reflected by changes in amphetamine urine recovery rates). In case of decreased amphetamine efficacy, discontinue Ascorbic Acid Injection administration. Standard monitoring of therapy is warranted.

In addition, acidification of urine by ascorbic acid will alter the excretion of certain drugs affected by the pH of the urine (e.g., fluphenazine) when administered concurrently. It has been reported that concurrent administration of ascorbic acid and fluphenazine has resulted in decreased fluphenazine plasma concentrations. Standard monitoring of therapy is warranted.

7.3Warfarin Limited case reports have suggested interference of ascorbic acid with the anticoagulation effects of warfarin, however, for patients on warfarin therapy treated with ascorbic acid doses up to 1000 mg/day (5 times the largest recommended single dose) for 2 weeks (twice the maximum recommended duration), no effect was observed. Standard monitoring for anti-coagulation therapy should continue during ascorbic acid treatment, as per standard of care.

7.4Laboratory Test Interference Because ascorbic acid is a strong reducing agent, it can interfere with numerous laboratory tests based on oxidation-reduction reactions (e.g., glucose, nitrite and bilirubin levels, leukocyte count, etc.). Chemical detecting methods based on colorimetric reactions are generally those tests affected. Ascorbic acid may lead to inaccurate results (false negatives) obtained for checking blood or urinary glucose levels, nitrite, bilirubin, and leukocytes if tested during or within 24 hours after infusion [see Warnings and Precautions ( 5.3 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on use of Ascorbic Acid Injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes; however, use of ascorbic acid (vitamin C) has been used during pregnancy for several decades and no adverse developmental outcomes are reported in the published literature [see Data] . There are dose adjustments for ascorbic acid (vitamin C) use during pregnancy [see Clinical Considerations]. Animal reproduction studies have not been conducted with Ascorbic Acid Injection.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Dose Adjustments During Pregnancy and Post-Partum Period Follow the U.S. Recommended Dietary Allowances (RDA) for pregnant women when considering use of Ascorbic Acid Injection for treatment of scurvy [see Dosage and Administration ( 2.3 )]. Data Human Data There are no available data on use of Ascorbic Acid Injection or another ascorbic acid injection in pregnant women.

However, a published meta–analysis of randomized studies evaluating a large number of pregnant women who took oral ascorbic acid (vitamin C) (through diet and supplementation) at doses ranging from 500 to1000 mg/day (2.5 to 5 times the recommended daily intravenous dose, respectively) [see Dosage and Administration ( 2.3 )] between the 9th and 16th weeks of pregnancy showed no increased risk of adverse pregnancy outcomes such as miscarriage, preterm premature rupture of membranes, preterm delivery or pregnancy induced hypertension when compared to placebo.

These data cannot definitively establish or exclude the absence of a risk with ascorbic acid (vitamin C) during pregnancy.

8.2Lactation Risk Summary There are no data on the presence of ascorbic acid (vitamin C) in human milk following intravenous dosing in lactating women. Ascorbic acid (vitamin C) is present in human milk after maternal oral intake. Maternal oral intake of ascorbic acid (vitamin C) exceeding the U.S.

Recommended Dietary Allowances (RDA) for lactation does not influence the ascorbic acid (vitamin C) content in breast milk or the estimated daily amount received by breastfed infants. There are no data on the effect of ascorbic acid (vitamin C) on milk production or the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ascorbic Acid Injection and any potential adverse effects on the breastfed child from Ascorbic Acid Injection or from the underlying maternal condition.

Follow the U.S. Recommended Dietary Allowances (RDA) for lactating women when considering use of Ascorbic Acid Injection for treatment of scurvy [see Dosage and Administration ( 2.3 )] .

8.4Pediatric Use Ascorbic Acid Injection is indicated for the short term (up to 1 week) treatment of scurvy in pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. The safety profile of ascorbic acid in pediatric patients is similar to adults; however, pediatric patients less than 2 years of age may be at higher risk of oxalate nephropathy following ascorbic acid administration due to age-related decreased glomerular filtration [see Warnings and Precautions ( 5.1 )] .

Ascorbic Acid Injection is not indicated for use in pediatric patients less than 5 months of age.

8.5Geriatric Use Glomerular filtration rate is known to decrease with age and as such may increase risk for oxalate nephropathy following ascorbic acid administration in elderly population [see Warnings and Precautions ( 5.1 )] .

8.6 Renal Impairment Ascorbic Acid Injection…

🤰 Pregnancy ~1 min read ▾

These data cannot definitively establish or exclude the absence of a risk with ascorbic acid (vitamin C) during pregnancy.

🧒 Pediatric Use 102 words ▾

Ascorbic Acid Injection is not indicated for use in pediatric patients less than 5 months of age.

🧓 Geriatric Use 36 words ▾

🆘 Overdosage 42 words ▾

10 OVERDOSAGE Overdose with ascorbic acid may cause nausea, vomiting, diarrhea, facial flushing, rash, headache, fatigue or disturbed sleep. If overdose of Ascorbic Acid Injection occurs, immediately discontinue administration and treat symptoms and signs of overdose, avoiding additional intake of ascorbic acid.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The exact mechanism of action of ascorbic acid for the treatment of symptoms and signs of scurvy (a disorder caused by severe deficiency in vitamin C) is unknown; however, administration of ascorbic acid in patients with scurvy is thought to restore the body pool of ascorbic acid.

12.3Pharmacokinetics In a single pharmacokinetic study, healthy male and female adults (n=8) were given a single intravenous dose of 1000 mg ascorbic acid (5 times the largest recommended single dose) infused over a 30 minute period. The mean peak exposure to ascorbic acid was 436.2 μM and occurred at the end of the 30 minute infusion. Distribution Ascorbic acid is distributed widely in the body, with large concentrations found in the liver, leukocytes, platelets, glandular tissues, and lens of the eye.

Based on data from oral exposure, ascorbic acid is known to be distributed into breast milk and crosses the placental barrier. Elimination When the body is saturated with ascorbic acid, the plasma concentration will be about the same as that of the renal threshold; if further amounts are then administered, most of it is excreted in the urine. When body tissues are not saturated and plasma concentration is low, administration of ascorbic acid results in little or no renal excretion.

The mean±SD (N=3) half-life observed in the single dose PK study, as described above, was 7.4±1.4 h. Metabolism A major route of metabolism of ascorbic acid involves its conversion to urinary oxalate, presumably through intermediate formation of its oxidized product, dehydroascorbic acid. Excretion There is a renal threshold for ascorbic acid (vitamin C); the vitamin is excreted by the kidney in large amounts only when the plasma concentration exceeds this threshold, which is approximately 1.4 mg/100 mL.

📦 How Supplied / Storage and Handling 106 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Ascorbic Acid Injection, USP for intravenous use is a colorless to pale yellow solution supplied as: NDC 84897-058-01 One 25,000 mg/50 mL (500 mg/mL) Pharmacy Bulk Package vial-50 mL Sterile vial NDC 84897-058-25 Tray pack of twenty five 25,000 mg/50 mL (500 mg/mL) Pharmacy Bulk Package vials. Store in a refrigerator at 2° to 8°C (36° to 46°F).

Protect from light. This product contains no preservative. See Dosage and Administration ( 2.1 ) for detailed instructions on preparation, dilution, and administration of Ascorbic Acid Injection, USP.

Excursions to ambient conditions for up to 30 days during storage or shipping are acceptable.

📋 Description 161 words ▾

11 DESCRIPTION Ascorbic Acid Injection, USP for intravenous use is a colorless to pale yellow, preservative-free, hypertonic, sterile, non-pyrogenic solution of ascorbic acid. Ascorbic Acid Injection, USP must be diluted with an appropriate infusion solution (e.g., 5% Dextrose Injection, USP; Sterile Water for Injection, USP) [see Dosage and Administration ( 2.1 )] . The chemical name of Ascorbic Acid is L-ascorbic acid.

The molecular formula is C 6 H 8 O 6 . It has the following structural formula: Each Ascorbic Acid Injection, USP, 50 mL, Pharmacy Bulk Package vial contains 25,000 mg ascorbic acid, equivalent to 28,125 mg sodium ascorbate. Each mL of Ascorbic Acid Injection, USP contains 500 mg of ascorbic acid (equivalent to 562.5 mg of sodium ascorbate which amounts to 65 mg sodium/mL of Ascorbic Acid injection, USP), 130 mg of Sodium bicarbonate, and 0.25 mg of edetate disodium.

Sodium hydroxide is added for pH adjustment (pH range 5.6-6.6). It contains no bacteriostatic or antimicrobial agent. formula

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

bacteriostatic: Describes a medicine that stops bacteria from multiplying so the body's own defenses can clear them.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nephrolithiasis: Kidney stones; hard mineral deposits that form in the kidneys.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 84897-0057-60 · Renova 84899-0001-01 · Enlightening →

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.

Ascorbic Acid 500 mg/mL Injection

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8 USE IN SPECIFIC POPULATIONS

8.6 Renal Impairment Ascorbic Acid Injection…

12 CLINICAL PHARMACOLOGY

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