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Davimet with Iron Iron, Folate 750 ug; 24 mg; 13.5 mg; 1.05 mg; 1.05 mg; 10 ug; 11 mg; 1.2 mg; 4.5 ug; 36 mg Tablet, 30-count — NDC 59088-0160-54 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Davimet with Iron Iron, Folate 750 ug; 24 mg; 13.5 mg; 1.05 mg; 1.05 mg; 10 ug; 11 mg; 1.2 mg; 4.5 ug; 36 mg Tablet, 30-count — NDC 59088-160-54 (Billing 59088-0160-54)

by PureTek Corporation · 30 TABLET in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Davimet with Iron Iron, Folate 750 ug; 24 mg; 13.5 mg; 1.05 mg; 1.05 mg; 10 ug; 11 mg; 1.2 mg; 4.5 ug; 36 mg Tablet from PureTek Corporation, marketed since Jun 2024 and currently FDA-listed. It is this product's only package size.

NDC 59088-0160-54
🏷️ FDA NDC (as labeled) 59088-160-54 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 59088-160-54 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59088 labeler · 160 product · 54 package
Package marketed since
Jun 3, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 5908816054 1
Medicaid fills, this package
25 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59088-160-54
Product NDC 59088-160
11-digit billing NDC 59088016054
NCPDP billing unit EA — each (per item)
UNII 3LE3D9D6OY, PQ6CK8PD0R, 25X51I8RD4, 68Y4CF58BV, 8K0I04919X, 1C6V77QF41 +6 more
SPL Set ID 1445921b-5bf4-ea48-e063-6294a90abb1a
Established class (EPC) Vitamin C; Vitamin D
Chemical class Ascorbic Acid; Vitamin D
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-03
Route ORAL
Dosage form TABLET
Substance VITAMIN A ACETATE; ASCORBIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; CHOLECALCIFEROL; IRON; RIBOFLAVIN; METHYLCOBALAMIN; SODIUM ASCORBATE; LEVOMEFOLATE CALCIUM; .ALPHA.-TOCOPHEROL ACETATE, DL-

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

GPI-14 78210000000500
GCN Seq No 086311
GCN 56006
HICL code 049750
Ingredient (HICL) Multivit No.62/Iron/Levomefol
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 88:28.00.00
AHFS class Multivitamin Preparations
FDB label name DAVIMET WITH IRON CHEW TABLET
FDB brand name Davimet With Iron
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 086311
  • GCN: 56006
  • GPI-14 (Medi-Span): 78210000000500
  • HICL (First Databank): 049750
  • AHFS class code: 88:28.00.00
Why two NDCs? The FDA registers this code as 59088-160-54 — 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 → 59088-0160-54. 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.

Clinical

Label name DAVIMET WITH IRON CHEW TABLET Ingredient Multivit No.62/Iron/Levomefol
🧪 What is this product?

Davimet with Iron is an oral tablet containing a combination of vitamins and minerals. The product includes vitamin A, B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, and methylcobalamin), vitamin C, vitamin D, vitamin E, iron, and folate. These ingredients are typically found in multivitamin and mineral supplements used to support overall nutrition and address dietary gaps. This product is marketed without an approved FDA 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.

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 $28.00 $839.91 / 30 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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 Marketing startMarketing endStatus
59088-0160-54 You're viewing this Main listing 30 TABLET in 1 BOTTLE, PLASTIC 2024-06-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Davimet with Iron 750 ug/1; 24 mg/1; 13.5 mg/1; 1.05 mg/1; 1.05 mg/1; 10 ug/1; 11 mg/1; 1.2 mg/1; 4.5 ug/1; 36 mgthis 59088-0160-54 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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 orange
ShapeRound
Size13 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 Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 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 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.

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.

Manufacturer & labeler

LabelerPureTek Corporation
Labeler code59088
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio178 products on file

More NDCs from PureTek Corporation labeler code 59088

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🆘 Overdosage 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 77 words ▾

INDICATIONS AND USAGE: Davimet™ with Iron Multivitamin Chewable Tablets are indicated for the treatment of iron deficiency anemia and folate deficiency, commonly seen in conditionssuch as extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. They are also indicated for condition in which irondeficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as casesof metabolic stress, and in convalescence.

⏱️ Dosage and Administration 16 words ▾

DOSAGE AND ADMINISTRATION: One tablet daily, to be dissolved in the mouth or chewed before swallowing.

⛔ 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 withhemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

⚠️ Warnings ~2 min read ▾

WARNING: Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. 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 accidentaloverdose, 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.

CAUTION: Should be chewed. PRECAUTIONS: Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviatingthe hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before thecorrect diagnosis is made.

Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered. Use only under the direction of a licensed healthcare practitioner.

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: Davimet™ with Iron Multivitamin Chewable Tablets are not recommended and should not be given to patients receiving levodopa because the action oflevodopa is antagonized by pyridoxine.

There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin orClopidogrel). Adverse Reactions: Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate. Iron: 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 Davimet™ with Iron Multivitamin Chewable Tablets after meals may controloccasional gastrointestinal disturbances.

Davimet™ with Iron Multivitamin Chewable Tablets is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergicand idiosyncratic reactions are possible at lower levels.

Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in somepatients

🤒 Adverse Reactions 116 words ▾

Adverse Reactions: Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate. Iron: 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 Davimet™ with Iron Multivitamin Chewable Tablets after meals may controloccasional gastrointestinal disturbances. Davimet™ with Iron Multivitamin Chewable Tablets is best absorbed when taken at bedtime.

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

🔄 Drug Interactions 45 words ▾

Drug Interactions: Davimet™ with Iron Multivitamin Chewable Tablets are not recommended and should not be given to patients receiving levodopa because the action oflevodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin orClopidogrel).

🆘 Overdosage 109 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. Othersymptoms include pallor and cyanosis, melena, shock, drowsiness and coma.

The estimated overdose of orally ingested iron is 300 mg/kg body weight. Whenoverdoses are ingested by children, severe reactions, including fatalities, have resulted. Davimet™ with Iron Multivitamin Chewable Tablets should be stored beyond the reach of children to prevent against accidental iron poisoning.

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

📦 How Supplied / Storage and Handling 66 words ▾

HOW SUPPLIED: Davimet™ with Iron Multivitamin Chewable Tablets are light orange with speckles, orange flavor, un-scored, round tablets. Available on prescription only in bottleof 30 tablets – NDC 59088-160-54. Dispense in a tight, light resistant container with a child resistant closure as defined in the USP/NF. All prescription substitutionsusing this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

📦 Storage and Handling 32 words ▾

Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 116 words ▾

DESCRIPTION: Each caplet contains: Vitamin A (as Retinyl Acetate).......................................750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)........ 60 mg Vitamin D3 (as Cholecalciferol)................................. 10 mcg (400 IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)........................

6.75mg Thiamin (as Thiamine Mononitrate)....................................... 1.05 mg Riboflavin................................................................................. 1.2 mg Niacin (as Niacinamide)..........................................................

13.5mg Vitamin B6 (as Pyridoxine Hydrochloride)............................. 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................................... 4.5 mcg Iron (as Iron Amino Acid Chelate)...............................................

11 mg Other Ingredients: Aspartame, CI 15985 / [Yellow 6 Lake], Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural OrangeFlavor, Stearic Acid (Vegetable Source), Sucrose. Phenylketonurics: Phenylalanine 3.0 mg Per Tablet.

⚠️ Precautions 134 words ▾

PRECAUTIONS: Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviatingthe hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before thecorrect diagnosis is made.

Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered. Use only under the direction of a licensed healthcare practitioner.

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.

📄 Package Label / Principal Display Panel 19 words ▾

Davimet™ with Iron Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label

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
25
Units reimbursed last 4 qtrs
750
Gross reimbursed last 4 qtrs
$21K
Avg / prescription
$839.91
Avg / unit
$27.9970
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
44% FFS 56% MCO
Fee-for-service · 11 Rx Managed care · 14 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 750 units · 16.4 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
16.416.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 16.4 /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.

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) ✓ 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.
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 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.
← 59088-0158-54 · PureTek 59088-0162-54 · 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.