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PNV Prenatol Multivitamin 3.4 mg; 20 mg; 120 mg; 1000 ug; 10 ug; 200 mg; 1500 ug; 3 mg; 25 mg; 2.6 mg Tablet, 30-count — NDC 59088-0078-54 package photo

PNV Prenatol Multivitamin 3.4 mg; 20 mg; 120 mg; 1000 ug; 10 ug; 200 mg; 1500 ug; 3 mg; 25 mg; 2.6 mg Tablet, 30-count

by PureTek Corporation · 30 TABLET in 1 BOTTLE, PLASTIC (59088-078-54)
NDC 59088-0078-54
🏷️ FDA NDC (as labeled) 59088-078-54 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 59088-078-54
Product NDC 59088-078
11-digit billing NDC 59088007854
UNII TLM2976OFR, 25X51I8RD4, PQ6CK8PD0R, A9R10K3F2F, P6YC3EG204, H0G9379FGK +12 more
UPC 0359088078549
SPL Set ID 583f0194-0306-f31b-e063-6394a90a2a10
Established class (EPC) Vitamin C; Vitamin B12; Vitamin D
Chemical class Ascorbic Acid; Vitamin B 12; Vitamin D
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-21
Route ORAL
Dosage form TABLET
Substance RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; .ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDR
Why two NDCs? The FDA registers this code as 59088-078-54 — 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 → 59088-0078-54. 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.

🏭 Manufacturer & labeler

LabelerPureTek Corporation
Labeler code59088
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio178 products on file
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.

🩺 Clinical

🧪 What is this product?

PNV Prenatol is an oral tablet containing a combination of vitamins and minerals. The product includes B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, cyanocobalamin, and levomefolate calcium), vitamin C, vitamin A, vitamin E, and mineral supplements (calcium, magnesium, zinc, manganese, and chromium). These ingredients are typically used together in prenatal formulations to support nutritional needs during pregnancy. This product is marketed without an FDA-approved application.

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.

💊 What it looks like

Color brown
ShapeOval
ImprintPTA18
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 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient 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 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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.

8 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.

💲 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.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PNV Prenatol 3.4 mg/1; 20 mg/1; 120 mg/1; 1000 ug/1; 10 ug/1; 200 mg/1; 1500 ug/1; 3 mg/1; 25 mg/1; 2.6 mgthis 59088-0078-54 PureTek 30 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0078-54 You're viewing this 30 TABLET in 1 BOTTLE, PLASTIC (59088-078-54) 2026-08-21 Active

🧭 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 FDA registers it as 59088-078-54, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59088-0078-54, written without dashes as 59088007854. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 59088-0078-54, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0078) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (54) identifies this exact package size and type. Together they name one specific package of one specific product.
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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🆘 Overdosage 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 49 words ▾

INDICATIONS AND USAGE: PNV Prenatol TM is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PNV Prenatol TM may be beneficial in improving the nutritional status of women prior to conception.

⏱️ Dosage and Administration 29 words ▾

DOSAGE AND ADMINISTRATION: Take one (1) PNV Prenatol™ tablet daily, preferably between meals, or as directed by a physician. Do not use in children under 12 years of age.

⛔ Contraindications 42 words ▾

CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folate may obscure its signs and symptoms.

⚠️ Warnings 58 words ▾

WARNINGS: 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 poison control center immediately. Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

🤒 Adverse Reactions 134 words ▾

Adverse Reactions: Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving PNV Prenatol™ tablets after meals may control occasional gastrointestinal disturbances.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

For use on the order of a physician. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 49 words ▾

Drug Interactions: PNV Prenatol™ tablets are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., heparin) and antiplatelet agents (e.g., aspirin or clopidogrel).

🆘 Overdosage 111 words ▾

OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma.

The estimated overdose of orally ingested iron is 300 mg/kg body weight. When excessive amounts of iron are ingested by children, severe reactions, including fatalities, have resulted. PNV Prenatol TM should be kept out of reach of children to prevent accidental iron poisoning.

Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

📦 How Supplied / Storage and Handling 31 words ▾

HOW SUPPLIED: PNV Prenatol™ tablets are light beige to beige, brown-speckled, oblong, film-coated tablets debossed with “PT A18” on one side. They are supplied in bottles of 30 tablets (NDC 59088-078-54).

📦 Storage and Handling 56 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Avoid excessive heat. Dispense in a tight, light-resistant container as defined in the USP/NF, with a child-resistant closure. Do not use if the seal under the bottle cap is broken. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

📋 Description 150 words ▾

Active Ingredients: Each tablet contains: Vitamin A (as retinyl acetate)…………...1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)……………….………………. 120 mg Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (as Vitamin E)……….....…….

30 mg Thiamin (as thiamine mononitrate)…………...……………….3 mg Riboflavin.....................…………………………...…...……. 3.4 mg Niacin (as niacinamide)…………………………....………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)………….………..50 mg Folate (as l-5-methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as cyanocobalamin)………………….……….10 mcg Choline (as choline bitartrate)..............................................55 mg Calcium (as calcium carbonate)……………………...…….

200 mg Iron (as ferrous fumarate)...................................................27 mg Iodine (as potassium iodide)............................................150 mcg Magnesium (as magnesium oxide)……………………...….200 mg Zinc (as zinc oxide)………………………………………....... 25 mg Selenium (as selenium amino acid chelate)……………….70 mcg Manganese (as manganese sulfate)………………………. 2.6 mg Chromium (as chromium polynicotinate)……………….....

45 mcg Molybdenum (as molybdenum amino acid chelate)……... 50 mcg Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59088-0022-54 · PureTek 59088-0083-00 · PureTek →
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.