Home › NDC Lookup › 72162-1656-01
Multivitamin with Fluoride .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D 2500 [iU]/1; 60 mg; 400 [iU]/1; 15 [iU]/1; 1.05 mg; 1.2 mg; 13.5 mg; 1.05 mg; 300 ug; 4.5 ug Tablet, Chewable, 100-count — NDC 72162-1656-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Multivitamin with Fluoride .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D 2500 [iU]/1; 60 mg; 400 [iU]/1; 15 [iU]/1; 1.05 mg; 1.2 mg; 13.5 mg; 1.05 mg; 300 ug; 4.5 ug Tablet, Chewable, 100-count — NDC 72162-1656-1 (Billing 72162-1656-01)

by Bryant Ranch Prepack · 100 TABLET, CHEWABLE in 1 BOTTLE

This is a package of 100 tablets of Multivitamin with Fluoride .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D 2500 [iU]/1; 60 mg; 400 [iU]/1; 15 [iU]/1; 1.05 mg; 1.2 mg; 13.5 mg; 1.05 mg; 300 ug; 4.5 ug Tablet, Chewable from Bryant Ranch Prepack, marketed since Jul 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 72162-1656-01
🏷️ FDA NDC (as labeled) 72162-1656-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Main listing for product 72162-1656 · Also comes in: 90 tablets 72162-1656-9
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 →

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 72162-1656-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72162 labeler · 1656 product · 1 package
Package marketed since
Jul 20, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 7216216561 4
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72162-1656-1
Product NDC 72162-1656
11-digit billing NDC 72162165601
NCPDP billing unit EA — each (per item)
UNII 81G40H8B0T, PQ6CK8PD0R, 9VU1KI44GP, WR1WPI7EW8, 8K0I04919X, TLM2976OFR +5 more
SPL Set ID 0800f4ef-1d98-4c0f-a016-501791973f66
Established class (EPC) Vitamin A; Vitamin C; Nicotinic Acid; Vitamin B6 Analog; Vitamin B12
Chemical class Vitamin A; Ascorbic Acid; Nicotinic Acids; Vitamin B 6; Analogs/Derivatives; Vitamin B 12
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-20
Route ORAL
Dosage form TABLET, CHEWABLE
Substance VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE

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

GCN Seq No 066016
GCN 28187
HICL code 036833
Ingredient (HICL) Pedi Multivit No.17 W-Fluoride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6H
Therapeutic class — specific (HIC3) Pediatric Vitamin Preparations
AHFS code 88:28.00.00
AHFS class Multivitamin Preparations
FDB label name MULTIVIT-FLUOR 0.5 MG TAB CHEW
FDB brand name Multivitamin With Fluoride
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 066016
  • GCN: 28187
  • HICL (First Databank): 036833
  • AHFS class code: 88:28.00.00
Why two NDCs? The FDA registers this code as 72162-1656-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 72162-1656-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name MULTIVIT-FLUOR 0.5 MG TAB CHEW Ingredient Pedi Multivit No.17 W-Fluoride
🧪 What is this product?

This is a chewable tablet containing multiple vitamins and fluoride taken by mouth. The B vitamins (thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin) are typically used to support energy metabolism and nerve function. Vitamin A, vitamin D, and vitamin C are commonly included in multivitamins to support vision, bone health, and immune function. Sodium fluoride is typically added to dental products to help strengthen tooth enamel. 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 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 Marketing startMarketing endStatus
72162-1656-01 You're viewing this Main listing 100 TABLET, CHEWABLE in 1 BOTTLE 2018-07-20 — Active
72162-1656-09 72162-1656-9 90 TABLET, CHEWABLE in 1 BOTTLE 2018-07-20 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, chewable in 1 bottle.
How does this package differ from NDC 72162-1656-09?
Both are Multivitamin with Fluoride .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D 2500 [iU]/1; 60 mg; 400 [iU]/1; 15 [iU]/1; 1.05 mg; 1.2 mg; 13.5 mg; 1.05 mg; 300 ug; 4.5 ug Tablet, Chewable — the drug itself is identical. This page's package is the 100-count one, while NDC 72162-1656-09 is the 90 tablets package.
What NDC number is used to bill for this package of Multivitamin with Fluoride .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D 2500 [iU]/1; 60 mg; 400 [iU]/1; 15 [iU]/1; 1.05 mg; 1.2 mg; 13.5 mg; 1.05 mg; 300 ug; 4.5 ug Tablet, Chewable?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 58657-0165-01 Method 100 tablets $0.099 — Availability likely —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 58657-0163-01 Method 100 tablets $0.102 — Availability likely —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 58657-0164-01 Method 100 tablets $0.107 — Availability likely —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 63629-1134-01 Bryant 100 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ugthis 72162-1656-01 Bryant 100 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 72162-1657-01 Bryant 100 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 63629-1135-01 Bryant 90 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 63629-1137-01 Bryant 90 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 63629-1138-01 Bryant 100 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 63629-1139-01 Bryant 90 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 72162-1655-01 Bryant 100 tablets — — FDA listed —
Multivitamin with Fluoride 2500 [iU]/1; 60 mg/1; 400 [iU]/1; 15 [iU]/1; 1.05 mg/1; 1.2 mg/1; 13.5 mg/1; 1.05 mg/1; 300 ug/1; 4.5 ug 63629-1136-01 Bryant 100 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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 yellow
ShapeRound
ImprintM164
Size9 mm
ScoringNot scored
FlavorOrange
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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 VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

7 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

LabelerBryant Ranch Prepack
Labeler code72162
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 72162

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 ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. M ultivitamin with Fluoride 0.5 mg Chewable Tablets provide 0.5 mg fluoride in tablet form for children 4-6 years of age in areas where the drinking water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with Fluoride 0.5 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements.

Children using Multivitamin with Fluoride 0 . 5 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

⏱️ Dosage and Administration 30 words ▾

DOSAGE AND ADMINISTRATION One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.

⚠️ Warnings 59 words ▾

WARNING Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. CAUTION Do not eat or drink dairy products within one hour of fluoride administration. Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

🤒 Adverse Reactions 11 words ▾

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.

🧬 Clinical Pharmacology 197 words ▾

CLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Multivitamin with Fluoride 0 . 5 mg Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet.

Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite .

The reaction may be expressed by the equation: Ca10(PO4)6(OH)2 + 2F- ------- Ca10(PO4)6F2 + 2OH- (Hydroxyapatite) (Fluorapatite) Three stages of fluoride deposition in tooth enamel can be distinguished: 1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. 2.

After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted. 3.

After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

📦 How Supplied / Storage and Handling 48 words ▾

HOW SUPPLIED Multivitamin Chewable tablets containing 0.5 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with “M164” on one side. NDC: 72162-1656-1: 100 Chewable Tabletss in a BOTTLE NDC: 72162-1656-9: 90 Chewable Tabletss in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

⚠️ Precautions 89 words ▾

PRECAUTION The suggested dose of Multivitamin with Fluoride 0 . 5 mg Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Multivitamin with Fluoride 0.5 mg Chewable Tablets: 1.

Determine the fluoride content of the drinking water from all major sources. 2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.

3. Periodically check to make sure that the child does not develop significant dental fluorosis.

📄 Package Label / Principal Display Panel 8 words ▾

Multivitamin/Fluoride Tab. Chew 0.5mg #100 Label Extended Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Multivitamin With Fluoride — 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 Multivitamin With Fluoride. 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
$343.82
Claims incl. refills
57
Beneficiaries
23
Spend / beneficiary
$14.95
Spend / claim
$6.03
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product 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 Bryant Ranch Prepack. 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 (72162-1656-09). 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?
Bryant Ranch Prepack 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.
← 72162-1655-01 · Bryant 72162-1657-01 · Bryant →
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.