Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Mang 1.5 mg; 900 ug; 7.5 mg; 300 mg; 25 ug; 45 ug; 20 mg; 5 mg; 25 mg; 25 mg Tablet, 3-count — NDC 00642-0207-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Mang 1.5 mg; 900 ug; 7.5 mg; 300 mg; 25 ug; 45 ug; 20 mg; 5 mg; 25 mg; 25 mg Tablet, 3-count — NDC 0642-0207-03 (Billing 00642-0207-03)

by Exeltis USA, Inc. · 1 BLISTER PACK in 1 BOX / 3 TABLET in 1 BLISTER PACK

This is a package of 3 tablets of Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Mang 1.5 mg; 900 ug; 7.5 mg; 300 mg; 25 ug; 45 ug; 20 mg; 5 mg; 25 mg; 25 mg Tablet from Exeltis USA, Inc., marketed since May 2001 and currently FDA-listed.

NDC 00642-0207-03
🏷️ FDA NDC (as labeled) 0642-0207-03 billing pads the labeler segment with a zero
This package
Contains3-count Pack sizes2 compare ↓
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ 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
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 0642-0207-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0642 labeler · 0207 product · 03 package
Package marketed since
May 4, 2001
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0306420207907
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0642-0207-03
Product NDC 0642-0207
11-digit billing NDC 00642020703
UNII 42Z2K6ZL8P, 81G40H8B0T, 568ET80C3D, PQ6CK8PD0R, 1C6V77QF41, LU4B53JYVE +12 more
UPC 0306420207907
SPL Set ID b9b71fa4-89c7-4f5b-8174-950649434ba5
Established class (EPC) Vitamin A; Vitamin C; Vitamin D; Vitamin B12; Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Vitamin A; Ascorbic Acid; Vitamin D; Vitamin B 12; Allergens
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-05-04
Route ORAL
Dosage form TABLET
Substance MANGANESE; VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SU

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

GPI-14 78310000000300
GPI class Strovite ONE
GCN Seq No 065035
GCN 21525
HICL code 035636
Ingredient (HICL) Mv,Min10/Folic Acid/D3/Ala/Lut
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6Z
Therapeutic class — specific (HIC3) Multivitamin Preparations
AHFS code 88:08.00.00
AHFS class Vitamin B Complex
FDB label name STROVITE ONE CAPLET
FDB brand name Strovite One
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 065035
  • GCN: 21525
  • GPI-14 (Medi-Span): 78310000000300
  • HICL (First Databank): 035636
  • AHFS class code: 88:08.00.00
Why two NDCs? The FDA registers this code as 0642-0207-03 — 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 → 00642-0207-03. 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 STROVITE ONE CAPLET Ingredient Mv,Min10/Folic Acid/D3/Ala/Lut
🧪 What is this product?

Strovite One is an oral tablet containing a combination of vitamins and minerals. The product includes B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, folic acid, biotin, and cyanocobalamin), vitamin C, vitamin D, vitamin A, and vitamin E, which are commonly included in multivitamin supplements to support general nutritional intake. It also contains minerals such as magnesium, zinc, selenium, copper, chromium, and manganese. This product is marketed without an approved FDA application.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 90 tablets
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 Per unit Per pack Marketing startMarketing endStatus
00642-0207-03 You're viewing this 1 BLISTER PACK in 1 BOX / 3 TABLET in 1 BLISTER PACK — — 2001-05-04 — Active
00642-0207-90 0642-0207-90 Main listing 90 TABLET in 1 BOTTLE $2.62 / ea $236.04 2001-05-04 — Active

This pack shows little to no recent Medicaid volume — the 90 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 3-count package — 1 blister pack in 1 box / 3 tablet in 1 blister pack.
How does this package differ from NDC 00642-0207-90?
Both are Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Mang 1.5 mg; 900 ug; 7.5 mg; 300 mg; 25 ug; 45 ug; 20 mg; 5 mg; 25 mg; 25 mg Tablet — the drug itself is identical. This page's package is the 3-count one, while NDC 00642-0207-90 is the 90 tablets package.
What NDC number is used to bill for this package of Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Mang 1.5 mg; 900 ug; 7.5 mg; 300 mg; 25 ug; 45 ug; 20 mg; 5 mg; 25 mg; 25 mg Tablet?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Strovite One Caplets 1.5 mg/1; 900 ug/1; 7.5 mg/1; 300 mg/1; 25 ug/1; 45 ug/1; 20 mg/1; 5 mg/1; 25 mg/1; 25 mgthis 00642-0207-03 Exeltis 3 tablets — — 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

🏛️
2001
On the market since
May 2001
📍
2026
Currently FDA-listed
25 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.

What it looks like

Color white
ShapeOval
ImprintEV0207
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7QWA1RIO01
    A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 461P5CJN6T
    Modified corn starch derived from cornstarch and treated with octenyl succinic anhydride. It acts as a thickener, stabilizer, and emulsifier to improve texture and prevent separation in the medicine.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII S033EH8359
    Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.

20 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

LabelerExeltis USA, Inc.
Labeler code00642
First marketedMay 2001
Product typeHuman Prescription Drug
Portfolio10 products on file

More NDCs from Exeltis USA, Inc. labeler code 00642

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 19 words ▾

INDICATIONS AND USAGE STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.

⏱️ Dosage and Administration 12 words ▾

DOSAGE AND ADMINISTRATION One caplet daily or as directed by a physician.

⛔ Contraindications 50 words ▾

CONTRAINDICATIONS STROVITE ® ONE is contraindicated in patients with hypersensitivity to any of its components. Folic Acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).

⚠️ Warnings and Cautions 123 words ▾

WARNING/PRECAUTIONS 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.

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.

🤒 Adverse Reactions 24 words ▾

ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in STROVITE ® ONE.

🔄 Drug Interactions 74 words ▾

Drug Interactions High doses of folic acid may result in decreased serum levels of anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hyper-calcemia 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.

🧒 Pediatric Use 7 words ▾

Pediatric Use Not recommended for pediatric use.

📦 How Supplied / Storage and Handling 37 words ▾

HOW SUPPLIED STROVITE ® ONE is a white, oblong caplet, debossed EV0207; available in bottles of 90 caplets (0642-0207-90) and as professional samples (0642-0207-03). Storage conditions: Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture.

📦 Storage and Handling 13 words ▾

Storage conditions: Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture.

📋 Description 156 words ▾

COMPOSITION Each caplet contains: Vitamin A (as beta carotene) 900 mcg RAE Vitamin C 300 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as d-alpha tocopheryl succinate) 67 mg Thiamin (as thiamine hydrochloride) 20 mg Riboflavin (vitamin B2) 5 mg Niacin (as niacinamide) 25 mg NE Vitamin B6 (as pyridoxine hydrochloride) 25 mg Folate (as folic acid) 1,670 mcg DFE Vitamin B12 (as cyanocobalamin) 50 mcg Biotin 100 mcg Pantothenic Acid (as calcium-D-pantothenate) 15 mg Magnesium (as magnesium oxide) 50 mg Zinc (as zinc oxide) 25 mg Selenium (as sodium selenate) 100 mcg Copper (as cupric sulfate) 1.5 mg Manganese (as manganese sulfate) 1.5 mg Chromium (as chromium chloride) 50 mcg Alpha Lipoic Acid 7.5 mg Lutein 5 mg Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol.

💬 Information for Patients 23 words ▾

Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

⚠️ Precautions 104 words ▾

Drug Interactions High doses of folic acid may result in decreased serum levels of anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hyper-calcemia 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 breastfeeding. Pediatric Use Not recommended for pediatric use.

📄 Package Label / Principal Display Panel 29 words ▾

PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label 0642-0207-90 Strovite ® ONE IRON FREE MULTIVITAMIN AND MINERAL SUPPLEMENT GLUTEN AND LACTOSE FREE 90 Caplets Rx Strovite One Bottle Label

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

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.
90 tablets00642-0207-90 155 Rx · $13,934
Drug total (last 4 qtrs): 155 Rx · 4,617 units · $13,934 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Strovite One Caplets (this brand).

Top reported reactions

Emotional Distress7
Pain7
Anxiety6
Anhedonia5
Back Pain4
Dyspnoea4
Economic Problem4

Age at onset

Adult10
Elderly3

Reporter sex

37 reports
Male · 59%
Female · 41%

Serious outcomes

Death4
Disabling2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 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 90 tablets (00642-0207-90). 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.