by Exeltis USA, Inc. · 5 BLISTER PACK in 1 BOX / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
This is a package of Vitafol Ultra Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic 200 mg; 15 mg; 9 mg; 25 ug; 330 ug; 30 mg; 1.6 mg; 1.8 mg; 2.5 mg Capsule, Liquid Filled from Exeltis USA, Inc., marketed since Sep 2013 and currently FDA-listed; retail pharmacies pay about $4.52 per unit (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC 00642-0093-30
🏷️ FDA NDC (as labeled)0642-0093-30billing pads the labeler segment with a zero
This package
Contains6 capsule, liquid filled in 1 blister packCost per ea$4.52 NADACPer package$135.68 / 30 capsules Pack sizes2 compare ↓
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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-1478516058000130
GPI classVitafol Ultra
GCN Seq No071399
GCN35169
HICL code040586
Ingredient (HICL)Pnv 67/Iron Ps/Folate No.1/Dha
HIC1 codeC
Therapeutic class — broad (HIC1)Electrolyte Balance/Metabolism/Nutrition
HIC2 codeC6
Therapeutic class — intermediate (HIC2)Vitamins
HIC3 codeC6F
Therapeutic class — specific (HIC3)Prenatal Vitamin Preparations
AHFS code20:04.04.00
AHFS classIron Preparations
FDB label nameVITAFOL ULTRA SOFTGEL
FDB brand nameVitafol Ultra
Legend statusQ — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
GSN (GCN sequence number):071399
GCN:35169
GPI-14 (Medi-Span):78516058000130
HICL (First Databank):040586
AHFS class code:20:04.04.00
Why two NDCs?
The FDA registers this code as 0642-0093-30 — 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 → 00642-0093-30. 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.
Label name VITAFOL ULTRA SOFTGELIngredient Pnv 67/Iron Ps/Folate No.1/Dha
🧪 What is this product?
Vitafol Ultra is a liquid-filled oral capsule containing multiple vitamins and minerals. The product includes B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, cyanocobalamin, and folic acid), vitamin C, vitamin D, vitamin E, and beta-carotene, which are typically used to support general nutritional needs. It also contains minerals including iron, zinc, copper, magnesium, and iodine. This product is marketed without an approved FDA application.
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 ea
Per package
Retail pharmacies payNADAC · weekly
$4.523
$135.68 / 30 capsules
Medicaid paysCMS SDUD · 12 mo
$4.47
$133.95 / 30 capsules
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 13% over the last 9 months.
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.
1 BLISTER PACK in 1 BOX / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
—
—
2013-09-23
—
Active
00642-0093-30 You're viewing thisMain listing
5 BLISTER PACK in 1 BOX / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
$4.52 / ea
$135.68
2013-09-23
—
Active
Swipe sideways for more columns →
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 5 blister pack in 1 box / 6 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of Vitafol Ultra Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic 200 mg; 15 mg; 9 mg; 25 ug; 330 ug; 30 mg; 1.6 mg; 1.8 mg; 2.5 mg Capsule, Liquid Filled?
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.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
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.
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, 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.
Warning Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.
🎯Indications and Usage40 words▾
USAGE Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.* Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.
⏱️Dosage and Administration21 words▾
DOSAGE AND ADMINISTRATION Before, during and after pregnancy, take one softgel capsule by mouth daily, or as directed by a physician.
⛔Contraindications101 words▾
CONTRAINDICATIONS Vitafol ® Ultra is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.
Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).
⚠️Warnings~1 min read▾
WARNINGS/PRECAUTIONS Vitafol ® Ultra contains soy and should be used with caution in patients with known sensitivity or allergy to soy. Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues.
Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Iodine should be used with caution in patients with an overactive thyroid. Prolonged use of iron salts may produce iron storage disease.
Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Avoid Overdosage.
Keep out of the reach of children. Drug Interactions Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions. Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
🤒Adverse Reactions71 words▾
ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® Ultra. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349.
🔄Drug Interactions119 words▾
Drug Interactions Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid.
Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
Consult appropriate references for additional specific vitamin-drug interactions.
📦How Supplied / Storage and Handling53 words▾
HOW SUPPLIED Vitafol ® Ultra is available as a dark blue, oval shaped softgel capsule imprinted "EV0093". Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules) (0642-0093-30) and as professional samples (0642- 0093-03). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
📦Storage and Handling12 words▾
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
📋Description158 words▾
COMPOSITION Amount per Capsule: VITAMINS AND MINERALS: Vitamin A (as beta carotene) 330 mcg RAE Vitamin C (as ascorbic acid) 30 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (680 mcg DFE from folic acid & 1020 mcg DFE from l-methylfolate calcium) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Iron (as polysaccharide iron complex) 29 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 20 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Docosahexaenoic acid (DHA) (from natural algal oil) 200 mg Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin.
Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
📄Package Label / Principal Display Panel33 words▾
PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Box 0642-0093-30 V ® VITAFOL ULTRA Prenatal Supplement with 200mg DHA Unit Dose Pack 30 Softgel Capsules R x DIETARY SUPPLEMENT U.S. PATENTED Vitafol Ultra
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:
contraindicated: Should not be used in that situation, because the risk is considered too high.
Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.
adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.
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.
cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.
Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.
hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.
hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.
hypercalcemia: A higher-than-normal level of calcium, a mineral, in the blood.
hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.
hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.
hypothyroidism: A condition where the thyroid gland makes too little thyroid hormone, which can slow the body down.
Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.
remission: A period when the signs and symptoms of cancer are reduced or have disappeared.
serious adverse event: A harmful event during treatment that is life-threatening, requires hospital care, or causes lasting harm.
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
77K
Units reimbursed last 4 qtrs
2.6M
Gross reimbursed last 4 qtrs
$11.61M
Avg / prescription
$150.84
Avg / unit
$4.4651
Latest quarter Q1 2026
17.9KRx
Medicaid pays / ea
$4.4651
gross reimbursed
vs
NADAC / ea
$4.5226
acquisition cost
=
Spread
−$0.0575
-1% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
90% MCO
Fee-for-service · 7,335 Rx Managed care · 69,651 Rx
State Medicaid map
Units reimbursed · per 100k residents
1.16,480
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
1Texas6,480 /100k
2Connecticut5,787 /100k
3Oklahoma3,699 /100k
4Florida890 /100k
5Louisiana366 /100k
6North Carolina329 /100k
7Alabama203 /100k
8Nebraska24.3 /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.
Drug total (last 4 qtrs): 76,986 Rx · 2,600,758 units · $11,612,744 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Vitafol Ultra — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Vitafol Ultra. 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
$3.7K
Claims incl. refills
25
Beneficiaries
19
Spend / beneficiary
$195.58
Spend / claim
$148.64
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.
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 Vitafol Ultra (this brand).
Top reported reactions
Premature Delivery19
Nausea4
Premature Labour4
Breech Presentation3
Covid-193
Dizziness3
Foetal Exposure During Pregnancy3
Age at onset
Adult8
Reporter sex
Male · 2%
Female · 98%
Serious outcomes
Hospitalization20
Reports over time (by year) — tap or hover for the count & year
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.
Finished prescription productMarketed 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
— 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)
✓ Available
Orange Book / therapeutic-equivalence data
— Not published for this NDCApplies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk
— Not published for this NDCMost 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.
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 Exeltis USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 4 capsules (00642-0093-03). 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?
Exeltis USA, 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.
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.