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Caffeine and Sodium Benzoate 125 mg/mL Injection, Solution — NDC 00517-2502-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Caffeine and Sodium Benzoate 125 mg/mL Injection, Solution — NDC 0517-2502-10 (Billing 00517-2502-10)

by American Regent, Inc. · 10 VIAL, SINGLE-DOSE in 1 BOX / 2 mL in 1 VIAL, SINGLE-DOSE

This is a package of Caffeine and Sodium Benzoate 125 mg/mL Injection, Solution from American Regent, Inc., marketed since Feb 1993 and currently FDA-listed. It is this product's only package size.

NDC 00517-2502-10
🏷️ FDA NDC (as labeled) 0517-2502-10 billing pads the labeler segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0517-2502-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0517 labeler · 2502 product · 10 package
Package marketed since
Feb 1, 1993
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0305172502100
Medicaid fills, this package
76 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0517-2502-10
Product NDC 0517-2502
11-digit billing NDC 00517250210
NCPDP billing unit ML — per mL (volume)
UNII 3G6A5W338E
UPC 0305172502100
SPL Set ID b2c6b352-f837-4903-8e4c-fb0a2b20bb60
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-02-01
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance CAFFEINE

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

GPI-14 61300010202010
GPI class Caffeine-Sodium Benzoate
GCN Seq No 019074
GCN 54190
HICL code 000010
Ingredient (HICL) Caffeine/Sodium Benzoate
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A1
Therapeutic class — intermediate (HIC2) Cardiac Stimulants
HIC3 code A1B
Therapeutic class — specific (HIC3) Xanthines
AHFS code 28:20.32.00
AHFS class Respiratory And Cns Stimulants
FDB label name CAFFEINE-SOD BENZOAT 250 MG/ML
FDB brand name Caffeine And Sodium Benzoate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 019074
  • GCN: 54190
  • GPI-14 (Medi-Span): 61300010202010
  • HICL (First Databank): 000010
  • AHFS class code: 28:20.32.00
Why two NDCs? The FDA registers this code as 0517-2502-10 — 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 → 00517-2502-10. 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.

Clinical

Label name CAFFEINE-SOD BENZOAT 250 MG/ML Ingredient Caffeine/Sodium Benzoate
📗 Our plain-language guide HelloPharmacist
  • It is used short term to treat apnea of prematurity, which means pauses in breathing in premature infants. It is given as an injection or an oral solution by the healthcare team.
  • The baby usually gets a one-time loading dose into a vein, then a smaller maintenance dose about every 24 hours. The maintenance dose can be given into a vein or by mouth. The dose...
  • Babies may be jittery or irritable, have a fast heart rate, have feeding problems, or have a rash. Blood sugar and urine output can also change. Tell the care team if you notice an...
  • Yes. Necrotizing enterocolitis, a serious intestinal problem in premature infants, was seen in trials. A cause was not proven, and the team watches closely for it. Too much caffein...
📖 Read our full Caffeine guide →

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.

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 $10.02 $200.49 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00517-2502-10 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 BOX / 2 mL in 1 VIAL, SINGLE-DOSE 1993-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Caffeine and Sodium Benzoate 125 mg/mLthis 00517-2502-10 American 10 vials — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
1993
On the market since
Feb 1993
📍
2026
Currently FDA-listed
33 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Caffeine 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 125 mg / 1 mL UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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.

Manufacturer & labeler

LabelerAmerican Regent, Inc.
Labeler code00517
First marketedFeb 1993
Product typeHuman Prescription Drug
Portfolio72 products on file

More NDCs from American Regent, Inc. labeler code 00517

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 58 words ▾

INDICATIONS AND USAGE Caffeine and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Caffeine and Sodium Benzoate Injection may be administered by intramuscular or slow intravenous injection. Some clinicians suggest that when used as a mild CNS stimulant to overcome fatigue, oral doses of 100-200 mg of anhydrous caffeine are required. One manufacturer recommends that citrated caffeine be administered orally in dosages of 65-325 mg (about 32-162 mg of anhydrous caffeine) 3 times daily.

Another manufacturer recommends an oral dosage of 250 mg of anhydrous caffeine in an extended-release formulation once daily, but warns that the drug should not be administered less than 6 hours before retiring. Analeptic use of caffeine is strongly discouraged by most clinicians. However, the manufacturer of Caffeine and Sodium Benzoate Injection recommends intramuscular, or in emergency respiratory failure, intravenous injection of 500 mg of the drug (about 250 mg of anhydrous caffeine) or a maximum single dose of 1 gram (about 500 mg of anhydrous caffeine) for the treatment of respiratory depression associated with overdosage of CNS depressants, including narcotic analgesics and alcohol, and with electric shock.

The usual dose is 0.5 g (7 ½ grains) as frequently as directed by the physician. The maximum safe dose is 0.5 g and the total dose in 24 hours should rarely exceed 2.5 g. Parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

🤰 Pregnancy 61 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with Caffeine and Sodium Benzoate Injection. It is also not known whether Caffeine and Sodium Benzoate Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Caffeine and Sodium Benzoate Injection should be given to a pregnant woman only if clearly needed.

🆘 Overdosage 81 words ▾

OVERDOSAGE Acute toxicity involving caffeine has been reported rarely. Mild delirium, insomnia, diuresis, dehydration, and fever commonly occur with overdosage. More serious symptoms of overdosage include cardiac arrhythmias and clonic-tonic convulsions.

In adults, IV doses of 57 mg/kg of body weight and oral doses of 18.50 grams have been fatal. In one 5-year-old patient, death occurred following oral ingestion of approximately 3 grams of caffeine. Convulsions may be treated with IV administration of diazepam or a barbiturate such as pentobarbital sodium.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Caffeine is pharmacologically similar to the other xanthine drugs, such as theobromine and theophylline; however, these three agents differ in the intensity of their actions on various structures. Caffeine's CNS and skeletal muscle effects are greater than those of the other xanthines. In all other areas, theophylline has greater activity than caffeine, although some studies report that caffeine has greater diuretic effect than theobromine.

The increased levels of intracellular cyclic-AMP mediate most of caffeine's pharmacologic actions. Caffeine competitively inhibits phosphodiesterase, the enzyme that degrades cyclic 3'- 5' adenosine monophosphate. Caffeine stimulates all levels of the CNS.

Caffeine's cortical effects are milder and of shorter duration than those of the amphetamines. In slightly larger doses, caffeine stimulates medullary vagal, vasomotor and respiratory centers, promoting bradycardia, vasoconstriction, and increased respiratory rate. Caffeine produces a positive inotropic effect of the myocardium and a positive chronotropic effect at the sinoatrial node, causing transient increases in heart rate, force of contraction, cardiac output and heart work.

In doses greater than 250 mg, the centrally mediated vagal effects of caffeine may be masked by increased sinus rates; tachycardia, extrasystoles, or other major ventricular arrhythmias may result. Caffeine constricts cerebral vasculature. In contrast, the drug directly dilates peripheral blood vessels, decreasing peripheral vascular resistance.

The effect of this decrease in peripheral vascular resistance (and possibly that of vagal cardiac stimulation) on blood pressure is offset by increased cardiac output (and possibly stimulation of the medullary vasomotor area). The overall effect of caffeine on heart rate and blood pressure depends on whether CNS or peripheral effects predominate. Therapeutic doses of caffeine increase blood pressure only slightly.

Caffeine stimulates voluntary skeletal muscle, increasing the force of contraction and decreasing muscular fatigue. The drug also stimulates gastric acid secretion from parietal cells. Caffeine increases renal blood flow and glomerular filtration rate and decreases proximal tubular reabsorption of sodium and water, resulting in mild diuresis.

Caffeine stimulates glycogenolysis and lipolysis, but increase in blood glucose and in plasma lipids are insignificant in normal patients. Tolerance may develop to the diuretic, cardiovascular, and CNS effects of caffeine. Pharmacokinetics Caffeine is rapidly distributed throughout the body tissues, readily crossing the placenta and blood-brain barrier.

Approximately 17% of the drug is bound to plasma proteins. Caffeine has approximately a half-life (T ½) of 3-4 hours in adults. In adults, the drug is rapidly metabolized in the liver to 1-methyluric acid, 1-methylxanthine and 7-methylxanthine.

Caffeine and its metabolites are excreted primarily by the kidneys.

📦 How Supplied / Storage and Handling 45 words ▾

HOW SUPPLIED Caffeine and Sodium Benzoate Injection, USP 250 mg/mL NDC 0517-2502-10 2 mL Single Dose Vials Packed in boxes of 10. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30"C (59°-86°F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN2502 Rev. 11/05

📋 Description 58 words ▾

DESCRIPTION Caffeine and Sodium Benzoate Injection, USP is a clear, sterile, nonpyrogenic, solution of Caffeine Alkaloid. Each mL contains: Caffeine (anhydrous) 125 mg; Sodium Benzoate (added to increase the solubility of Caffeine) 125 mg; Water for Injection, USP q.s. pH (range 6.5 to 8.5) adjusted with Hydrochloric Acid and/or Sodium Hydroxide. For intramuscular or slow intravenous administration only.

⚠️ Precautions 200 words ▾

PRECAUTIONS Large doses of caffeine may produce headache, excitement, agitation, a condition resembling anxiety neurosis, scintillating scotoma, hyperesthesia, tinnitus, muscle tremors or twitches, diuresis, tachycardia, extrasystoles, and other cardiac arrhythmias. Further CNS depression may occur when already depressed patients are too vigorously treated with Caffeine and Sodium Benzoate Injection. Caffeine and other xanthines may enhance the cardiac inotropic effects of ß-adrenergic stimulating agents.

Caffeine has also been reported to increase its own metabolism and that of other drugs, including phenobarbital and aspirin. Caffeine produces false-positive elevations of serum urate as measured by the Bittner method. The drug also produces slight increases in urine levels of vanilamandelic acid (VMA), catecholamines, and 5-hydrocyindoleacetic acid.

Because high urine levels of VMA or catecholamines may result in false-positive diagnosis of pheochromocytoma or neuroblastoma, caffeine intake should be avoided during tests for these disorders. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with Caffeine and Sodium Benzoate Injection.

It is also not known whether Caffeine and Sodium Benzoate Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Caffeine and Sodium Benzoate Injection should be given to a pregnant woman only if clearly needed.

🧬 Pharmacokinetics 64 words ▾

Pharmacokinetics Caffeine is rapidly distributed throughout the body tissues, readily crossing the placenta and blood-brain barrier. Approximately 17% of the drug is bound to plasma proteins. Caffeine has approximately a half-life (T ½) of 3-4 hours in adults. In adults, the drug is rapidly metabolized in the liver to 1-methyluric acid, 1-methylxanthine and 7-methylxanthine. Caffeine and its metabolites are excreted primarily by the kidneys.

📄 Package Label / Principal Display Panel 74 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 0517-2502-01 Rx Only Caffeine and Sodium Benzoate Injection, USP 250 mg/mL (125 mg/mL Caffeine) For IM or Slow IV Use 2 mL Single-Dose Vial Discard Unused Portion Carton Labeling NDC 0517-2502-10 Rx Only Caffeine and Sodium Benzoate Injection, USP 250 mg/mL (125 mg/mL Caffeine) For Intramuscular or Slow Intravenous Use 10 X 2 mL Single-Dose Vials Discard Unused Portion Container Label Carton Labeling

Serialization Label Serialization Label

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 – Q4 2025 · 4 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
76
Units reimbursed last 4 qtrs
76
Gross reimbursed last 4 qtrs
$761.86
Avg / prescription
$10.02
Avg / unit
$10.0245
Latest quarter Q4 2025
15Rx
Fee-for-service vs managed care ⓘ
84% FFS 16% MCO
Fee-for-service · 64 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: 12 units · 0.2 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported 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: 64 units · 0.2 per 100k residents 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
0.20.2
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 Minnesota 0.2 /100k
2 California 0.2 /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.

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 Caffeine and Sodium Benzoate — the ingredient across all brands.

Top reported reactions

Blood Pressure Decreased2
Cardiac Arrest2
Circulatory Collapse2
Malaise2
Nausea2
Overdose2
Product Label Issue2

Reporter sex

0 reports

Serious outcomes

Hospitalization9
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 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 Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by American Regent, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
American Regent, 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.
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.
← 00517-2340-01 · American 00517-2505-25 · American →
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.