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Phendimetrazine Tartrate 35 mg Tablet, 1,000-count — NDC 63629-2489-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Phendimetrazine Tartrate 35 mg Tablet, 1,000-count — NDC 63629-2489-1 (Billing 63629-2489-01)

by Bryant Ranch Prepack · 1000 TABLET in 1 BOTTLE

This is a package of 1,000 tablets of Phendimetrazine Tartrate 35 mg Tablet from Bryant Ranch Prepack, marketed since Jul 2018 and currently FDA-listed. It is this product's only package size.

NDC 63629-2489-01
🏷️ FDA NDC (as labeled) 63629-2489-1 billing pads the package segment with a zero
Rx only Generic On market CIII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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 63629-2489-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63629 labeler · 2489 product · 1 package
Package marketed since
Jul 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1,000 EA per package
Barcode (UPC-A, from the NDC)
3 6362924891 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63629-2489-1
Product NDC 63629-2489
11-digit billing NDC 63629248901
NCPDP billing unit EA — each (per item)
RxCUI 979549
UNII 6985IP0T80
Application # ANDA085588
SPL Set ID 75f6c4bc-ed72-498a-822c-ecc2a13df958
Established class (EPC) Sympathomimetic Amine Anorectic
Physiologic effect Appetite Suppression; Increased Sympathetic Activity
DEA schedule CIII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-01
Route ORAL
Dosage form TABLET
Substance PHENDIMETRAZINE TARTRATE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 61200050100305
GPI class Phendimetrazine Tartrate
GCN Seq No 005170
GCN 20852
HICL code 002115
Ingredient (HICL) Phendimetrazine Tartrate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J8
Therapeutic class — intermediate (HIC2) Anti-Obesity - Anorexics
HIC3 code J8A
Therapeutic class — specific (HIC3) Anti-Obesity - Anorexic Agents
AHFS code 28:20.08.04
AHFS class Amphetamine Derivatives
FDB label name PHENDIMETRAZINE 35 MG TABLET
FDB brand name Phendimetrazine Tartrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005170
  • GCN: 20852
  • GPI-14 (Medi-Span): 61200050100305
  • HICL (First Databank): 002115
  • AHFS class code: 28:20.08.04
  • RxCUI (RxNorm): 979549
Why two NDCs? The FDA registers this code as 63629-2489-1 — 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 → 63629-2489-01. 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.

RxNorm drug class

This medicine belongs to the Sympathomimetic Amine Anorectic class.

Pharmacologic class Sympathomimetic Amine Anorectic
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PHENDIMETRAZINE 35 MG TABLET Ingredient Phendimetrazine Tartrate
📖 What it is MedlinePlus · NLM

Phendimetrazine is used as a short-term treatment with diet to help certain people who are obese to lose weight. Phendimetrazine is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a short-term prescription aid for weight loss — not a cure for obesity. It works by stimulating your central nervous system in a way that may reduce your appetite, helping you...
  • What exactly is phendimetrazine supposed to do for me?
  • That's a decision your prescriber makes based on your situation. The tablet is taken two to three times a day before meals, while the extended-release capsule is taken just once in...
  • How do I know which form — the tablet or the extended-release capsule — is right for me?
📖 Read our full Phendimetrazine guide →
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.
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
63629-2489-01 You're viewing this Main listing 1000 TABLET in 1 BOTTLE 2021-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phendimetrazine Tartrate 35 mg 10702-0077-01 KVK-TECH, 100 tablets $0.132 AA Availability likely —
Phendimetrazine Tartrate 35 mg 64850-0440-01 Elite 100 tablets $0.132 AA Availability likely —
Phendimetrazine Tartrate 35 mg 69543-0410-10 Virtus 100 tablets $0.132 AA Availability likely —
Phendimetrazine Tartrate 35 mg 10702-0045-01 KVK-TECH, 100 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 10702-0078-01 KVK-TECH, 100 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 17224-0800-28 Calvin 28 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 43063-0510-07 PD-Rx 7 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 50090-0715-00 A-S 30 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 50090-2235-00 A-S 100 tablets — AA Discontinued —
Phendimetrazine Tartrate 35 mg 50090-6552-02 A-S 90 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mgthis 63629-2489-01 Bryant 1000 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 66267-0394-60 NuCare 60 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 68071-3509-06 NuCare 60 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 68071-3839-09 NuCare 90 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 68788-7236-01 Preferred 14 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 71335-0074-00 Bryant 120 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 71335-0324-00 Bryant 120 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 71335-1840-00 Bryant 120 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 72162-2044-00 Bryant 1000 tablets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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
ImprintE;76
Size7 mm
ScoringScored — splits in 2
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.

🧪 Avoiding an ingredient? See Phendimetrazine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 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.

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
Application holderACERTIS PHARMACEUTICALS LLC
FDA applicationANDA085588 (ANDA)
Labeler code63629
First marketedJul 2018
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio4,442 products on file

More NDCs from Bryant Ranch Prepack labeler code 63629

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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 words ▾

INDICATIONS AND USAGE Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below.

⏱️ Dosage and Administration 50 words ▾

DOSAGE AND ADMINISTRATION Usual Adult Dose: 1 tablet (35 mg) b.i.d. or t.i.d., one hour before meals. Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets t.i.d.

⛔ Contraindications 41 words ▾

CONTRAINDICATIONS Known hypersensitivity or idiosyncratic reactions to sympathomimetics. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism and glaucoma. Highly nervous or agitated patients. Patients with a history of drug abuse. Patients taking other CNS stimulants, including monoamine oxidase inhibitors.

⚠️ Warnings 102 words ▾

WARNINGS Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded. Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis.

Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

🤒 Adverse Reactions 42 words ▾

ADVERSE REACTIONS Cardiovascular: Palpitation, tachycardia, elevated blood pressure. Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain. Genitourinary: Urinary frequency, dysuria, changes in libido.

🤰 Pregnancy 45 words ▾

Usage in Pregnancy Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or who may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

🧒 Pediatric Use 17 words ▾

Usage in Children Phendimetrazine tartrate is not recommended for use in children under 12 years of age.

🆘 Overdosage 102 words ▾

OVERDOSAGE Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse.

Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Poisoning may result in convulsions, coma and death. The management of overdosage is largely symptomatic.

It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics”. It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects, may be involved, for example.

Adult obese subjects instructed in dietary management and treated with “anorectic” drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short term clinical trials. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks.

The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration, thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

📦 How Supplied / Storage and Handling 64 words ▾

HOW SUPPLIED Phendimetrazine Tartrate Tablet 35 mg is a yellow, bisected, round tablet; imprinted “E 76”. NDC 63629-2489-1 bottles of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant, container as defined in the USP, with a child-resistant closure (as required). Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 92 words ▾

DESCRIPTION Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2 s ,3 s ,)-3,4-dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is as follows: Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol; insoluble in chloroform, acetone, ether and benzene.

Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. Inactive Ingredients: confectioner’s sugar (sucrose and corn starch), lactose monohydrate, povidone, pregelatinized starch, silicon dioxide and stearic acid. The yellow tablets also contain: FD&C yellow No.

5 (see PRECAUTIONS ).

⚠️ Precautions 178 words ▾

PRECAUTIONS Caution is to be exercised in prescribing phendimetrazine tartrate for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine and the concomitant dietary regimen. Phendimetrazine may decrease the hypotensive effect of guanethidine.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. The phendimetrazine tartrate yellow tablets contain FD&C yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals.

Although the overall incidence of FD&C yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Usage in Pregnancy Safe use in pregnancy has not been established.

Until more information is available, phendimetrazine tartrate should not be taken by women who are or who may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards. Usage in Children Phendimetrazine tartrate is not recommended for use in children under 12 years of age.

🔒 Drug Abuse and Dependence 154 words ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Phendimetrazine tartrate tablets are defined by the Drug Enforcement Administration as a Schedule III controlled substance. Dependence Phendimetrazine tartrate is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused and the possibility of abuse of phendimetrazine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG.

Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

🔒 Controlled Substance 18 words ▾

Controlled Substance Phendimetrazine tartrate tablets are defined by the Drug Enforcement Administration as a Schedule III controlled substance.

📄 Package Label / Principal Display Panel 6 words ▾

Phendimetrazine Tartrate 35mg Tablet (CIII) Label

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

About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
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

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.
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.
← 63629-2477-01 · Bryant 63629-2495-01 · 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.