by XGen Pharmaceuticals DJB, Inc. · 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 XGen Pharmaceuticals DJB, Inc., marketed since Nov 2019 and currently FDA-listed. It is this product's only package size.
NDC 39822-1100-01
🏷️ FDA NDC (as labeled)39822-1100-1billing pads the package segment with a zero
🗂️ 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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-1482200010002005
GPI classFolic Acid
GCN Seq No002362
GCN94801
HICL code001062
Ingredient (HICL)Folic Acid
HIC1 codeC
Therapeutic class — broad (HIC1)Electrolyte Balance/Metabolism/Nutrition
HIC2 codeC6
Therapeutic class — intermediate (HIC2)Vitamins
HIC3 codeC6M
Therapeutic class — specific (HIC3)Folic Acid Preparations
AHFS code88:08.00.00
AHFS classVitamin B Complex
FDB label nameFOLIC ACID 50 MG/10 ML VIAL
FDB brand nameFolic Acid
Legend statusF — 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 39822-1100-1 — a 5-4-1 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 package segment → 39822-1100-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
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.
Label name FOLIC ACID 50 MG/10 ML VIALIngredient 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...
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.
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
Price system
Per mL
Per package
Retail pharmacies payNADAC · weekly
Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo
$12.76
$127.56 / 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.
How the units are derivedThis package is 10 ML; the HCPCS unit is 0.1 MG, so one package = 50 billing units.
Medicare Part B spend (2026 (Q1))$341 · 386 claims · $0.88 per claim (all NDCs under J1808)
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.
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.
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, 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.
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.
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.
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 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 Administration183 words▾
DOSAGE AND ADMINISTRATION Parenteral Administration : Intramuscular (IM), intravenous (IV) and subcutaneous (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.
⚠️Warnings137 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 Reactions36 words▾
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB, Inc. at 1-866- 390-4411 or FDA at 1-800-FDA-1088 or www.fda. gov/medwatch.
🧬Clinical Pharmacology47 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 Handling85 words▾
HOW SUPPLIED Folic Acid Injection, USP 50 mg per 10 mL (5 mg per mL) is available as: Product NDC: 39822-1100-1 10 mL Multiple Dose, in a flip-top vial, packaged individually. 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. Manufactured in India. Manufactured by: Anthea Pharma Private Limited Mfg.
Lic: TS/SGY/2023-112201 Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Revised: August 2025 FOLI-AN-PI-00 1500105 logo Rx Only
📋Description154 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, USP 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, USP q.s. Sodium hydroxide for pH adjustment (8.0 to 11.0). folic acid structure
⚠️Precautions24 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 Panel82 words▾
PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Label NDC 39822-1100-1 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 PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Carton NDC 39822-1100-1 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 foli-an-vl-00 foli-an-cs-00
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.
Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.
anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.
Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.
Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.
intramuscular: An injection given deep into a muscle; often written as IM.
intravenous: Given directly into a vein through a needle or thin tube; often written as IV.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
parenteral: Given by injection or drip into the body rather than swallowed by mouth.
relapse: The return of a cancer after a period of improvement or disappearance.
remission: A period when the signs and symptoms of cancer are reduced or have disappeared.
Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.
subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.
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
3.8K
Units reimbursed last 4 qtrs
14.1K
Gross reimbursed last 4 qtrs
$180K
Avg / prescription
$47.58
Avg / unit
$12.7561
Latest quarter Q4 2025
669Rx
Fee-for-service vs managed care ⓘ
18% FFS82% MCO
Fee-for-service · 676 Rx Managed care · 3,107 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.2166
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Kentucky166 /100k
2Montana97.4 /100k
3New Mexico17.6 /100k
4Florida4.2 /100k
5New York4.1 /100k
6Tennessee3.5 /100k
7North Carolina3.5 /100k
8Minnesota3.2 /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.
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
— Not published for this NDCNo photo available yet for this listing.
Inactive ingredients (structured)
— Not published for this NDCThe labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)
— Not published for this NDCCMS 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 XGen Pharmaceuticals DJB, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
XGen Pharmaceuticals DJB, 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 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.
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.
