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Dextrose 50 mg/mL Injection, Solution — NDC 00409-7100-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dextrose 50 mg/mL Injection, Solution — NDC 0409-7100-02 (Billing 00409-7100-02)

by Hospira, Inc. · 12 POUCH in 1 CASE / 2 BAG in 1 POUCH / 250 mL in 1 BAG

This is a package of Dextrose 50 mg/mL Injection, Solution from Hospira, Inc., marketed since Jun 2005 and currently FDA-listed, this package's marketing is listed to end Oct 2026. It is the main listing for this product, which comes in 3 package sizes.

NDC 00409-7100-02
🏷️ FDA NDC (as labeled) 0409-7100-02 billing pads the labeler segment with a zero
This package
Contains250 mL in 1 bag Medicaid pays$0.6091 / unit · 12 mo Per package$3,654.60 / 6000 ml · Medicaid Pack sizes3 compare ↓
Also priced by: Part D plans $0.0214/unit — full pricing hub ↓
Main listing for product 0409-7100 · Also comes in: 10 pouches 0409-7100-66 10 pouches 0409-7100-67
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 0409-7100-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0409 labeler · 7100 product · 02 package
Package marketed since
Jun 27, 2005
Package marketing ended
Oct 31, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 0409710002 6
Medicaid fills, this package
12 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Dextrose Monohydrate (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0435-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0437-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0436-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Nov 30, 2021 · Terminated — Lack of sterility assurance: bag has the potential to leak. (Pfizer Inc.) · FDA recall D-0265-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0409-7100-02
Product NDC 0409-7100
11-digit billing NDC 00409710002
NCPDP billing unit ML — per mL (volume)
UNII LX22YL083G
Application # NDA019466
SPL Set ID 10e98cb0-31a5-4ad1-3eaa-aa4af387a42d
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-06-27
Marketing end 2026-11-30
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 80100020002015
GPI class Dextrose
GCN Seq No 059911
GCN 25842
HICL code 000915
Ingredient (HICL) Dextrose 5 % In Water
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5J
Therapeutic class — specific (HIC3) Iv Solutions: Dextrose-Water
AHFS code 40:20.00.00
AHFS class Caloric Agents
FDB label name DEXTROSE 5%-WATER IV SOLN
FDB brand name Dextrose In Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 059911
  • GCN: 25842
  • GPI-14 (Medi-Span): 80100020002015
  • HICL (First Databank): 000915
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 1795609
Why two NDCs? The FDA registers this code as 0409-7100-02 — 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 → 00409-7100-02. 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 Other irrigating solutions class.

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

Clinical

Label name DEXTROSE 5%-WATER IV SOLN Ingredient Dextrose 5 % In Water
📗 Our plain-language guide HelloPharmacist
  • Dextrose is essentially the same glucose your body gets from food, but in this case it's going directly into the bloodstream. That's important in two main situations: when blood su...
  • Why is my loved one being given dextrose through an IV — isn't sugar just food?
  • Yes, that's a real concern. Dextrose raises blood glucose, which is exactly what you need when blood sugar is too low. But if it's given too fast or in too high a concentration, it...
  • Can dextrose actually cause high blood sugar? I thought it was for low blood sugar.
📖 Read our full Dextrose 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 $0.6091 $3,654.60 / 6000 ml
Medicare drug plans payPart D · Q2 2026 $0.0214 $128.40 / 6000 ml
Medicare Part B allowsASP · J7060 $1.649 / J7060 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)0409-7100-02
11-digit billing NDC00409-7100-02
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7060
Descriptor5% DEXTROSE/WATER (500 ML = 1 UNIT)
Billing units / pkg0 units
How the units are derivedThis package is 250 ML; the HCPCS unit is 500 ML, so one package = 0 billing units.
Medicare Part B spend (2026 (Q1))$9,431 · 3,615 claims · $2.61 per claim (all NDCs under J7060)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00409-7100-02 You're viewing this Main listing 12 POUCH in 1 CASE / 2 BAG in 1 POUCH / 250 mL in 1 BAG 2005-06-27 Oct 31, 2026 Active
00409-7100-66 0409-7100-66 10 POUCH in 1 CASE / 5 BAG in 1 POUCH / 50 mL in 1 BAG 2005-08-04 — Discontinued by firm
00409-7100-67 0409-7100-67 10 POUCH in 1 CASE / 5 BAG in 1 POUCH / 100 mL in 1 BAG 2005-09-14 Nov 30, 2026 Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 12 pouch in 1 case / 2 bag in 1 pouch / 250 ml in 1 bag.
What NDC number is used to bill for this package of Dextrose 50 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextrose 50 mg/mL 65219-0464-50 FRESENIUS 100 ml — AP FDA listed —
Dextrose 50 mg/mL 63323-0624-10 Fresenius 1000 ml — AP FDA listed —
Dextrose 50 mg/mLthis 00409-7100-02 Hospira, 12 pouches — AP FDA listed —
Dextrose 50 mg/mL 84549-0460-20 ProPharma 500 ml — AP FDA listed —
Dextrose 50 mg/mL 65219-0456-60 FRESENIUS 50 ml — AP FDA listed —
Dextrose 50 mg/mL 65219-0460-20 FRESENIUS 500 ml — AP FDA listed —
Dextrose 50 mg/mL 65219-0458-30 FRESENIUS 250 ml — AP FDA listed —
Dextrose 50 mg/mL 65219-0462-10 FRESENIUS 1000 ml — AP FDA listed —
Dextrose 50 mg/mL 17271-0720-02 Becton 50 ml — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2005
On the market since
Jun 2005
📍
2026
Currently FDA-listed
21 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

🧪 Avoiding an ingredient? See Dextrose 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 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.

1 inactive ingredient 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.

Manufacturer & labeler

LabelerHospira, Inc.
Application holderHOSPIRA INC
FDA applicationNDA019466 (NDA)
Labeler code00409
First marketedJun 2005
Product typeHuman Prescription Drug
Portfolio317 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product. Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Only for intravenous infusion. ( 2.1 ) • Infusion rate depends on the age, weight, clinical, and metabolic conditions of the patient and concomitant therapy. See full prescribing information for more information on preparation, administration, and dosing considerations. ( 2.1 , 2.2 , 2.3 )

2.1Important Administration Instructions Dextrose Injection (5%) is intended for intravenous use. • Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L. • To avoid venous irritation, consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater [see Warnings and Precautions (5.4) ] . • Do not administer Dextrose Injection (5%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. • Use of a final filter is recommended during administration of parenteral solutions, where possible. • Discard the unused portion. • Do not use the Dextrose Injection (5%) ADD-Vantage TM diluent containers with chemotherapy agents.

2.2Important Preparation Information Visually inspect the Dextrose Injection (5%) for particulate matter and discoloration. Do not administer Dextrose Injection (5%) if the solution is cloudy, there are precipitates, and the container is damaged. To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5%): • Use a non-vented infusion set or close the vent on a vented set. • Use a dedicated line without any connections (do not connect flexible containers in series). • Do not pressurize the flexible container to increase flow rates. • If using a pumping device to administer Dextrose Injection (5%), turn off the pump before the container is empty.

To Open : • Peel overwrap at corner and remove solution container. o Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. • Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Assemble Vial and Flexible Diluent Container : 1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap.

(SEE FIGURE 2.) NOTE: Once the breakaway cap has been removed, do not access the vial with the syringe. b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2.

Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click.

(SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3.

Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.

To Reconstitute the Drug : 1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2.

With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3.

Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4.

Mix container contents thoroughly and use within the specified time. 5. Look through the bottom of the vial to verify that the stopper has been removed… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 136 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: • 5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose flexible plastic ADD-Vantage TM diluent containers: 50 mL, 100 mL and 250 mL. This dextrose product is intended to be used as a diluent for the contents of an ADD- Vantage vial or a single-dose powdered drug vial with 20 mm closure using the ADD-Vantage ADDAPTOR TM . Injection: • 5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in single-dose flexible plastic ADD-Vantage TM diluent containers: 50 mL, 100 mL and 250 mL.

This dextrose product is intended to be used as a diluent for the contents of an ADD-Vantage vial or a single-dose powdered drug vial with 20 mm closure using the ADD-Vantage ADDAPTOR TM . ( 3 )

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Dextrose Injection (5%) is contraindicated in patients with: • Clinically significant hyperglycemia [see Warnings and Precautions (5.2) ] . • Known hypersensitivity to dextrose [see Warnings and Precautions (5.3) ] . • Clinically significant hyperglycemia. ( 4 ) • Known hypersensitivity to dextrose. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Neonatal Hypoglycemia : Closely monitor blood glucose concentration to ensure adequate glycemic control. ( 5.1 ) • Hyperglycemia and Hyperosmolar Hyperglycemic State : Use with caution in patients with known subclinical or overt diabetes mellitus. ( 5.2 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs.

( 5.3 ) • Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops. ( 2.1 , 5.4 ) • Hyponatremia : Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. ( 5.5 ) • Electrolyte Imbalance and Fluid Overload : Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration.

( 5.6 ) • Refeeding Syndrome : Monitory laboratory parameters. ( 5.7 )

5.1Neonatal Hypoglycemia Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with Dextrose Injection (5%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

5.2Hyperglycemia and Hyperosmolar Hyperglycemic State The use of Dextrose Injection (5%) in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration, and electrolyte losses [see Warnings and Precautions (5.6) , Use in Specific Populations (8.4) ] .

Patients with underlying CNS disease and renal impairment who receive dextrose infusions may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain levels within normal limits while administering Dextrose Injection (5%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5%) administration.

5.3Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (5%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.4Phlebitis and Thrombosis The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [see Dosage and Administration (2.1) ] . If thrombophlebitis develops, remove the catheter as soon as possible.

5.5Hyponatremia Dextrose Injection (5%) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs or certain antiepileptic, psychotropic, and cytotoxic drugs) [see Drug Interactions (7.1) , Use in Specific Populations (8.4) ] .

Avoid Dextrose Injection (5%) in patients with or at risk for hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations, chloride concentrations, fluid status, acid-base balance, and neurologic status [see Warnings and Precautions (5.6) ] .

5.6Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (5%). Depending on the administered volume and the infusion rate, Dextrose Injection (5%) can cause fluid overload, including pulmonary edema. Avoid Dextrose Injection (5%… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 207 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also described elsewhere in the labeling: • Neonatal Hypoglycemia [see Warnings and Precautions (5.1) ] • Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Phlebitis and Thrombosis [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] • Electrolyte Imbalance, Fluid Overload and Hypervolemia [see Warnings and Precautions (5.6) ] • Refeeding Syndrome [see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of Dextrose Injection (5%) were identified in clinical trials or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritus, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection (both systemic and at the injection site), vein thrombosis, phlebitis, and electrolyte imbalance.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 169 words ▾

7 DRUG INTERACTIONS Effects on Glycemic Control and Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Avoid use of Dextrose Injection in patients receiving drugs associated with hyponatremia. ( 7.1 )

7.1Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (5%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.1 , 5.2 , 5.5 , 5.6 )] . Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Concomitant administration of Dextrose Injection (5%) with drugs associated with hyponatremia may increase the risk of developing hyponatremia.

Drugs associated with hyponatremia include diuretics and those that cause SIADH (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), arginine vasopressin analogs, certain antiepileptic, psychotropic, and cytotoxic drugs). Avoid use of Dextrose Injection (5%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ].

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia and imbalances in fluid/electrolytes; monitor serum glucose concentrations, volume status, and electrolytes. ( 8.4 )

8.1Pregnancy Risk Summary Dextrose Injection (5%) has been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use in other stages of pregnancy, exposure during pregnancy in general is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with dextrose.

The background risk of major birth defects and miscarriage for the indicated populations are 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 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary Dextrose Injection (5%) has been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the effects of Dextrose Injection (5%) on levels of glucose in human milk, on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dextrose Injection (5%) and any potential adverse effects on the breastfed infant from Dextrose Injection (5%) or from the underlying maternal condition.

8.4Pediatric Use Dextrose Injection (5%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product. Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia. Therefore, they need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Dextrose Injection (5%) can cause imbalances in fluid and electrolytes in pediatric patients and requires close monitoring of volume status and plasma electrolyte concentrations, particularly in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5 , 5.6) ] . In very low birth weight neonates, excessive or rapid administration of Dextrose Injection (5%) may increase the risk of intracerebral hemorrhage.

8.5Geriatric Use Dextrose Injection (5%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.

In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of the infusion rate, and patients should be closely monitored during Dextrose Injection (5%) treatment.

🤰 Pregnancy 121 words ▾

8.1Pregnancy Risk Summary Dextrose Injection (5%) has been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use in other stages of pregnancy, exposure during pregnancy in general is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with dextrose.

The background risk of major birth defects and miscarriage for the indicated populations are 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 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 154 words ▾

8.4Pediatric Use Dextrose Injection (5%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product. Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia. Therefore, they need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Dextrose Injection (5%) can cause imbalances in fluid and electrolytes in pediatric patients and requires close monitoring of volume status and plasma electrolyte concentrations, particularly in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5 , 5.6) ] . In very low birth weight neonates, excessive or rapid administration of Dextrose Injection (5%) may increase the risk of intracerebral hemorrhage.

🧓 Geriatric Use 151 words ▾

8.5Geriatric Use Dextrose Injection (5%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.

In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of the infusion rate, and patients should be closely monitored during Dextrose Injection (5%) treatment.

🆘 Overdosage 94 words ▾

10 OVERDOSAGE A medication error resulting in a high infusion rate of Dextrose Injection (5%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.2 , 5.6 )] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (5%) treatment, discontinue the infusion.

Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [see Warnings and Precautions (5.2 , 5.6 )] .

🧬 Clinical Pharmacology 57 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

12.3Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

📦 How Supplied / Storage and Handling 193 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, USP (5%) is a clear, colorless, sterile solution of dextrose supplied in single-dose flexible plastic ADD-Vantage TM diluent containers. This dosage form is intended to be used as a diluent for the contents of an ADD-Vantage vial or a single-dose powdered drug vial with a 20 mm closure using the ADD-Vantage ADDAPTOR TM . Unit of Sale Strength Volume NDC 0409-7100-66 Case of 50 – 50 mL bags 5% (2.5 g/50 mL) (50 mg/mL) 50 mL bags NDC 0409-7100-67 Case of 50 – 100 mL bags 5% (5 g/100 mL) (50 mg/mL) 100 mL bags NDC 0409-7100-02 Case of 24 – 250 mL bags 5% (12.5 g/250 mL) (50 mg/mL) 250 mL bags Do not remove the container from the overwrap until intended for use.

Use the product immediately after the introduction of additives. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze.

To contact Pfizer’s Medical Information Department, please visit www.pfizermedinfo.com or call 1‑800-438‑1985. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1143-4.0 Hospira logo

📋 Description ~1 min read ▾

11 DESCRIPTION Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O.

Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1) ] . Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 mL sizes. See Table 1 for the content and characteristics of this solution.

The solution contains no bacteriostatic, antimicrobial agent or added buffer and is supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5). Table 1.

Contents and Characteristics of 5% Dextrose Injections, USP Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous per Container mOsmol per Liter 5% Dextrose Injection, USP (50 mg/mL) 50 mL 2.5 grams 8.5 253 100 mL 5 grams 17 253 250 mL 12.5 grams 42.5 253 Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses.

It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula dextrose

🧬 Pharmacokinetics 10 words ▾

12.3Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.

🧬 Pharmacodynamics 23 words ▾

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

🧪 Nonclinical Toxicology 28 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with dextrose to evaluate the drug’s carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 25 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with dextrose to evaluate the drug’s carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

📄 Recent Major Changes 35 words ▾

Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 06/2025 Contraindications ( 4 ) 06/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 06/2025

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL - 50 mL Bag Label PULL INNER PLUG/STOPPER AND MIX DRUG BEFORE USE ADD-Vantage™ Unit NDC 0409-7100-68 5% DEXTROSE Injection, USP 50 mL EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g. 253 mOsmol/LITER (calc.). pH 4.3 (3.2 TO 6.5) DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. FOR USE ONLY WITH ADD-Vantage™ SYSTEM COMPONENTS.

SINGLE- DOSE CONTAINER. FOR IV USE. USUAL DOSAGE: SEE PACKAGE INSERT.

STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS.

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA Rx ONLY IM-4480 14475201 3 v CONTAINS DEHP PRINCIPAL DISPLAY PANEL - 50 mL Bag Label

PRINCIPAL DISPLAY PANEL - 100 mL Bag Label PULL INNER PLUG/STOPPER AND MIX DRUG BEFORE USE ADD-Vantage™ Unit NDC 0409-7100-69 5% DEXTROSE Injection, USP 100 mL EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g. 253 mOsmol/LITER (calc.). pH 4.3 (3.2 TO 6.5) DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. FOR USE ONLY WITH ADD-Vantage™ SYSTEM COMPONENTS.

SINGLE-DOSE CONTAINER. FOR IV USE. USUAL DOSAGE: SEE PACKAGE INSERT.

STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS.

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA Rx ONLY IM-4481 14475601 3 v CONTAINS DEHP PRINCIPAL DISPLAY PANEL - 100 mL Bag Label

PRINCIPAL DISPLAY PANEL - 250 mL Bag Label LOT EXP. PULL INNER PLUG/STOPPER AND MIX DRUG BEFORE USE ADD-Vantage™ Unit NDC 0409-7100-04 5% DEXTROSE Injection, USP 250 mL EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g. 253 mOsmol/LITER (calc). pH 4.3 (3.2 TO 6.5) DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION.

FOR USE ONLY WITH ADD-Vantage™ SYSTEM COMPONENTS. SINGLE- DOSE CONTAINER. FOR INTRAVENOUS USE.

USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA Hospira 3 v CONTAINS DEHP IM-4482 14475801 PRINCIPAL DISPLAY PANEL - 250 mL Bag Label

PRINCIPAL DISPLAY PANEL - OVERWRAP – WR-0583 One/ADD-Vantage™ Unit TO OPEN–PEEL AT CORNER For use only with ADD-Vantage™ system components. The overwrap is a moisture barrier. Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly.

If leaks are found, discard unit as sterility may be impaired. Rx only 14475901 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira WR-0583 PRINCIPAL DISPLAY PANEL - OVERWRAP – WR-0583

PRINCIPAL DISPLAY PANEL - OVERWRAP – WR-0581 TO OPEN – PEEL AT NOTCH Five/ADD-Vantage™ Units For use only with ADD-Vantage™ system components. The overwrap is a moisture barrier. Use units within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date.

After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Rx only 14475301 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira WR-0581 PRINCIPAL DISPLAY PANEL - OVERWRAP – WR-0581

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
12
Units reimbursed last 4 qtrs
7K
Gross reimbursed last 4 qtrs
$4.3K
Avg / prescription
$355.30
Avg / unit
$0.6091
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 12 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 7,000 units · 35.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
35.835.8
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
🏆 Top states by units · per 100k residents
1 New York 35.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 pouches00409-7100-66 60 Rx · $28,820
10 pouches00409-7100-67 No Medicaid data
Drug total (last 4 qtrs): 72 Rx · 37,500 units · $33,084 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Dextrose (this brand).

Top reported reactions

Myelosuppression1,752
Nausea1,001
Vomiting927
Acute Kidney Injury792
White Blood Cell Count Decreased719
Pyrexia700
Dyspnoea672

Age at onset

Neonate221
Infant60
Child116
Adolescent60
Adult1,763
Elderly965

Reporter sex

13,286 reports
Male · 46%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization6,665
Death2,065
Life-threatening1,812
Disabling718
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,042 0
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

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 ✓ Available
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 it is currently marketed — but Hospira, Inc. has reported a marketing end date of 2026-11-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 pouches (00409-7100-66), 10 pouches (00409-7100-67). 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?
Hospira, Inc. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7060 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.