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Folic Acid 5 mg/mL Injection, Solution — NDC 63323-0184-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Folic Acid 5 mg/mL Injection, Solution — NDC 63323-184-10 (Billing 63323-0184-10)

by Fresenius Kabi USA, LLC · 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

This is a package of Folic Acid 5 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Sep 2000 and currently FDA-listed. It is this product's only package size.

NDC 63323-0184-10
🏷️ FDA NDC (as labeled) 63323-184-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 63323-184-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 184 product · 10 package
Package marketed since
Sep 5, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6332318410 0
Medicaid fills, this package
10,149 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) 63323-184-10
Product NDC 63323-184
11-digit billing NDC 63323018410
NCPDP billing unit ML — per mL (volume)
RxCUI 237786
UNII 935E97BOY8
Application # ANDA089202
SPL Set ID e215318c-4f8b-4711-ae76-f370d1da0f3b
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-09-05
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance FOLIC ACID
TE code (Orange Book) AP · RLD · RS

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

GPI-14 82200010002005
GPI class Folic Acid
GCN Seq No 002362
GCN 94801
HICL code 001062
Ingredient (HICL) Folic Acid
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6M
Therapeutic class — specific (HIC3) Folic Acid Preparations
AHFS code 88:08.00.00
AHFS class Vitamin B Complex
FDB label name FOLIC ACID 5 MG/ML VIAL
FDB brand name Folic Acid
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002362
  • GCN: 94801
  • GPI-14 (Medi-Span): 82200010002005
  • HICL (First Databank): 001062
  • AHFS class code: 88:08.00.00
  • RxCUI (RxNorm): 237786
Why two NDCs? The FDA registers this code as 63323-184-10 — 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 → 63323-0184-10. 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.

RxNorm drug class

This medicine belongs to the Folic acid and derivatives class.

Drug family (ATC) Folic acid and derivatives, Other diagnostic agents
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 FOLIC ACID 5 MG/ML VIAL Ingredient Folic Acid
📗 Our plain-language guide HelloPharmacist
  • It treats megaloblastic anemia caused by low folic acid. This is anemia where your bone marrow makes oversized, immature red blood cells. Replacing the missing folate lets your bod...
  • Take it as your prescriber directs, usually once a day. The oral solutions can be taken with or without food, and you should measure them with an oral dosing syringe from us. Injec...
  • Yes, this matters. Folic acid can hide pernicious anemia, a B12 deficiency anemia, so your blood counts may improve while nerve damage keeps getting worse. Your doctor should rule...
  • It's well tolerated, and side effects are mostly reported at much higher doses. These include nausea, bloating, gas, poor appetite and a bitter taste. Call your doctor right away f...
📖 Read our full Folic Acid 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 $6.71 $67.14 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1808 $0.051 / J1808 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)63323-184-10
11-digit billing NDC63323-0184-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1808
Descriptor0.1 MG
Billing units / pkg500 units
How the units are derivedThis package is 10; the HCPCS unit is 0.1 MG, so one package = 500 billing units.
Medicare Part B spend (2026 (Q1))$341 · 386 claims · $0.88 per claim (all NDCs under J1808)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
63323-0184-10 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE 2000-09-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Folic Acid 5 mg/mL 39822-1100-01 XGen 1 vial — AP FDA listed —
Folic Acid 5 mg/mLthis 63323-0184-10 Fresenius 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

🏛️
2000
On the market since
Sep 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

🧪 Avoiding an ingredient? See Folic Acid 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.

  • 15 mg / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 2 mg / 1 mL UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA089202 (ANDA)
Labeler code63323
First marketedSep 2000
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

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 ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

INDICATIONS AND USAGE: Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.

⏱️ Dosage and Administration 179 words ▾

DOSAGE AND ADMINISTRATION: Parenteral Administration : IM, IV and SC routes may be used if the disease is exceptionally severe or if gastrointestinal absorption may be, or is known to be, impaired. Usual Therapeutic Dosage — In adults and children (regardless of age): up to 1 mg daily.Resistant cases may require larger doses. Maintenance Level : When clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per day.

Patient should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy or chronic infection, the maintenance level may need to be increased. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⚠️ Warnings 137 words ▾

WARNINGS: WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.

This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.

🤒 Adverse Reactions 16 words ▾

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

🧬 Clinical Pharmacology 47 words ▾

CLINICAL PHARMACOLOGY: In man, an exogenous source of folate is required for nucleoprotein synthesis and maintenance of normal erythropoiesis. Folic acid, whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells and platelets in persons suffering from certain megaloblastic anemias.

📦 How Supplied / Storage and Handling 90 words ▾

HOW SUPPLIED: Folic Acid Injection, USP 50 mg per 10 mL (5 mg per mL) is available as: Product No. NDC No. 18410 63323-184-10 50 mg per 10 mL (5 mg per mL), 10 mL Multiple Dose, in a flip-top vial packaged individually.

18411 63323-184-11 50 mg per 10 mL (5 mg per mL), 10 mL Multiple Dose, in a flip-top vial, 10 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT.

Retain vial in carton until contents are used.

📋 Description 155 words ▾

DESCRIPTION: Folic Acid Injection, USP is a sterile, nonpyrogenic solution of sodium folate (prepared by the addition of sodium hydroxide to folic acid) in Water for Injection intended for intramuscular (IM), intravenous (IV) or subcutaneous (SC) use. Folic Acid is a complex organic compound present in liver, yeast and other substances, which may be prepared synthetically. It is a yellow or yellowish orange, odorless crystalline powder.

It is very slightly soluble in water, insoluble in alcohol, chloroform, ether; readily dissolves in dilute solutions of alkali hydroxides and carbonates. It is chemically designated as: L-Glutamic acid, N -[4-[[(2-amino-1-4-dihydro-4-oxo-6-pteridinyl) methyl] amino]benzoyl]-, and has the following structural formula. C 19 H 19 N 7 O 6 M.W.

441.40 Each mL contains: Sodium folate (equivalent to 5 mg folic acid); edetate disodium 2 mg; benzyl alcohol 15 mg (added as preservative); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide for pH adjustment (8.0 to 11.0). folic acid structure

⚠️ Precautions 24 words ▾

PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

📄 Package Label / Principal Display Panel 77 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Label Folic Acid Injection, USP 50 mg per 10 mL (5 mg/mL) For intramuscular, intravenous or subcutaneous use. 10 mL Multiple Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Carton Label Folic Acid Injection, USP 50 mg per 10 mL (5 mg per mL) For intramuscular, intravenous or subcutaneous use. 10 mL Multiple Dose Vial Rx only vial carton

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
10.1K
Units reimbursed last 4 qtrs
54.3K
Gross reimbursed last 4 qtrs
$364.7K
Avg / prescription
$35.94
Avg / unit
$6.7140
Latest quarter Q1 2026
2.1KRx
Fee-for-service vs managed care ⓘ
27% FFS 73% MCO
Fee-for-service · 2,789 Rx Managed care · 7,360 Rx
State Medicaid map
Alaska: 79 units · 10.8 per 100k residents AK Maine: no data reported ME Washington: 62 units · 0.8 per 100k residents WA Idaho: 79 units · 4.0 per 100k residents ID Montana: no data reported MT North Dakota: 29 units · 3.7 per 100k residents ND Minnesota: 143 units · 2.5 per 100k residents MN Wisconsin: no data reported WI Michigan: 29 units · 0.3 per 100k residents MI New York: 1,427 units · 7.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 154 units · 3.6 per 100k residents OR Nevada: 3,986 units · 125 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 59 units · 1.8 per 100k residents IA Illinois: 616 units · 4.9 per 100k residents IL Indiana: 170 units · 2.5 per 100k residents IN Ohio: 267 units · 2.3 per 100k residents OH Pennsylvania: 1,166 units · 9.0 per 100k residents PA New Jersey: 595 units · 6.4 per 100k residents NJ Massachusetts: 4,532 units · 64.7 per 100k residents MA California: 4,582 units · 11.8 per 100k residents CA Utah: 2 units · 0.1 per 100k residents UT Colorado: no data reported CO Nebraska: 195 units · 9.9 per 100k residents NE Missouri: 110 units · 1.8 per 100k residents MO Kentucky: 28,932 units · 639 per 100k residents KY West Virginia: no data reported WV Virginia: 273 units · 3.1 per 100k residents VA Maryland: 6 units · 0.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 75 units · 1.0 per 100k residents AZ New Mexico: 1,159 units · 54.8 per 100k residents NM Kansas: 26 units · 0.9 per 100k residents KS Arkansas: no data reported AR Tennessee: 735 units · 10.3 per 100k residents TN North Carolina: 2,586 units · 23.9 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 52 units · 1.3 per 100k residents OK Louisiana: 709 units · 15.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1 units · 0.0 per 100k residents GA D.C.: 111 units · 16.3 per 100k residents DC Hawaii: 5 units · 0.3 per 100k residents HI Texas: 704 units · 2.3 per 100k residents TX Florida: 665 units · 2.9 per 100k residents FL
Units reimbursed · per 100k residents
0.0639
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 Kentucky 639 /100k
2 Nevada 125 /100k
3 Massachusetts 64.7 /100k
4 New Mexico 54.8 /100k
5 North Carolina 23.9 /100k
6 D.C. 16.3 /100k
7 Louisiana 15.5 /100k
8 California 11.8 /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.

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

Medicare Part D (outpatient prescription) spending for Folic Acid — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Folic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$870.8K
Claims incl. refills
257.4K
Beneficiaries
188.1K
Spend / beneficiary
$4.63
Spend / claim
$3.38
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1808 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.
← 63323-0180-01 · Fresenius 63323-0185-05 · Fresenius →
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.