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Trihexyphenidyl Hydrochloride 5 mg Tablet, 40,008-count — NDC 00591-5337-77 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Trihexyphenidyl Hydrochloride 5 mg Tablet, 40,008-count — NDC 0591-5337-77 (Billing 00591-5337-77)

by Actavis Pharma, Inc. · 40008 TABLET in 1 CONTAINER

This is a package of 40,008 tablets of Trihexyphenidyl Hydrochloride 5 mg Tablet from Actavis Pharma, Inc., marketed since Nov 1987 and currently FDA-listed.

NDC 00591-5337-77
🏷️ FDA NDC (as labeled) 0591-5337-77 billing pads the labeler segment with a zero
This package
Contains40,008-count Pack sizes4 compare ↓
Product page 00591-5337-01 Also comes in: 100 tablets 0591-5337-01 1000 tablets 0591-5337-10 33000 tablets 0591-5337-00
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 0591-5337-77 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
0591 labeler · 5337 product · 77 package
Package marketed since
Jul 22, 2024
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0591533777 8
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-5337-77
Product NDC 0591-5337
11-digit billing NDC 00591533777
SPL Set ID a44d7803-164d-4a67-9356-581c45de8596
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-11-01
Dosage form TABLET
Substance TRIHEXYPHENIDYL HYDROCHLORIDE

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

GPI-14 73100070100320
GPI class Trihexyphenidyl HCl
GCN Seq No 004582
GCN 17563
HICL code 001900
Ingredient (HICL) Trihexyphenidyl Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6B
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Anticholinergic
AHFS code 12:08.04.00
AHFS class Antiparkinsonian Agents
FDB label name TRIHEXYPHENIDYL 5 MG TABLET
FDB brand name Trihexyphenidyl Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004582
  • GCN: 17563
  • GPI-14 (Medi-Span): 73100070100320
  • HICL (First Databank): 001900
  • AHFS class code: 12:08.04.00
Why two NDCs? The FDA registers this code as 0591-5337-77 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00591-5337-77. 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 TRIHEXYPHENIDYL 5 MG TABLET Ingredient Trihexyphenidyl Hcl
📗 Our plain-language guide HelloPharmacist
  • Trihexyphenidyl is used with other treatment for parkinsonism, and it often works well alongside levodopa. It is also used to control movement problems caused by certain medicines...
  • It can be taken before or after meals, depending on how you feel. If your mouth gets very dry, before meals may help, unless it upsets your stomach. If thirst bothers you after mea...
  • Dry mouth, blurred vision, dizziness, mild nausea, and nervousness are common. They often ease as your body adjusts. Tell your doctor if they bother you, because adjusting the dose...
  • Please don't stop it suddenly. Stopping abruptly can make parkinsonism symptoms flare and may cause a serious reaction called neuroleptic malignant syndrome. Talk with your prescri...
📖 Read our full Trihexyphenidyl guide →

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: 100 tablets 1000 tablets 33000 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00591-5337-01 0591-5337-01 Main listing 100 TABLET in 1 BOTTLE, PLASTIC $0.1191 / ea $11.91 1987-11-01 — Active
00591-5337-10 0591-5337-10 1000 TABLET in 1 BOTTLE, PLASTIC $0.1191 / ea $119.10 1987-11-01 — Active
00591-5337-00 0591-5337-00 33000 TABLET in 1 BAG — — — — Active
00591-5337-77 You're viewing this 40008 TABLET in 1 CONTAINER — — — — Active

You're viewing the largest of 4 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 40,008-count package — 40008 tablet in 1 container.
How does this package differ from NDC 00591-5337-01?
Both are Trihexyphenidyl Hydrochloride 5 mg Tablet — the drug itself is identical. This page's package is the 40,008-count one, while NDC 00591-5337-01 is the 100 tablets package.
What NDC number is used to bill for this package of Trihexyphenidyl Hydrochloride 5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Trihexyphenidyl Hydrochloride 5 mg 70954-0211-10 Novitium 100 tablets $0.119 AA Availability likely —
Trihexyphenidyl Hydrochloride 5 mgthis 00591-5337-77 Actavis 40008 tablets — — FDA listed —
Trihexyphenidyl Hydrochloride 5 mg 51407-0266-01 Golden 100 tablets — AA FDA listed —
Trihexyphenidyl Hydrochloride 5 mg 63850-0022-01 Natco 100 tablets — AA FDA listed —
Trihexyphenidyl Hydrochloride 5 mg 70518-1140-00 REMEDYREPACK 30 tablets — AA FDA listed —
Trihexyphenidyl Hydrochloride 5 mg 70518-1657-01 REMEDYREPACK 100 tablets — AA FDA listed —
Trihexyphenidyl Hydrochloride 5 mg 70518-2409-02 REMEDYREPACK 100 tablets — AA 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

🏛️
1987
On the market since
Nov 1987
📍
2026
Currently FDA-listed
39 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintDAN;DAN;5337
Size1 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 Trihexyphenidyl 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedNov 1987
Product typeDrug For Further Processing
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 00591

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 FDA label FDA SPL

The complete FDA label for this product, 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 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 59 words ▾

INDICATIONS This drug is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether trihexyphenidyl HCl may best be given before or after meals should be determined by the way the patient reacts.

Postencephalitic patients, who are usually more prone to excessive salivation, may prefer to take it after meals and may, in addition, require small amounts of atropine which, under such circumstances, is sometimes an effective adjuvant. If trihexyphenidyl HCl tends to dry the mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, the thirst sometimes induced can be allayed by mint candies, chewing gum or water.

Trihexyphenidyl HCl in Idiopathic Parkinsonism As initial therapy for parkinsonism, 1 mg may be administered the first day. The dose may then be increased by 2 mg increments at intervals of three to five days, until a total of 6 to 10 mg is given daily. The total daily dose will depend upon what is found to be the optimal level.

Many patients derive maximum benefit from this daily total of 6 to 10 mg, but some patients, chiefly those in the postencephalitic group, may require a total daily dose of 12 to 15 mg. Trihexyphenidyl HCl in Drug-Induced Parkinsonism The size and frequency of dose of trihexyphenidyl HCl needed to control extrapyramidal reactions to commonly employed tranquilizers, notably the phenothiazines, thioxanthenes, and butyrophenones, must be determined empirically. The total daily dosage usually ranges between 5 and 15 mg, although, in some cases, these reactions have been satisfactorily controlled on as little as 1 mg daily.

It may be advisable to commence therapy with a single 1 mg dose. If the extrapyramidal manifestations are not controlled in a few hours, the subsequent doses may be progressively increased until satisfactory control is achieved. Satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of the tranquilizer on instituting trihexyphenidyl HCl therapy and then adjusting dosage of both drugs until the desired ataractic effect is retained without onset of extrapyramidal reactions.

It is sometimes possible to maintain the patient on a reduced trihexyphenidyl HCl dosage after the reactions have remained under control for several days. Instances have been reported in which these reactions have remained in remission for long periods after trihexyphenidyl HCl therapy was discontinued. Concomitant Use of Trihexyphenidyl HCl with Levodopa When trihexyphenidyl HCl is used concomitantly with levodopa, the usual dose of each may need to be reduced.

Careful adjustment is necessary, depending on side effects and degree of symptom control. Trihexyphenidyl HCl dosage of 3 to 6 mg daily, in divided doses, is usually adequate. Concomitant Use of Trihexyphenidyl HCl with Other Parasympathetic Inhibitors Trihexyphenidyl HCl may be substituted, in whole or in part, for other parasympathetic inhibitors.

The usual technique is partial substitution initially, with progressive reduction in the other medication as the dose of trihexyphenidyl HCl is increased. Trihexyphenidyl Hydrochloride Tablets - The total daily intake of trihexyphenidyl HCl tablets is tolerated best if divided into 3 doses and taken at mealtimes. High doses (> 10 mg daily) may be divided into 4 parts, with 3 doses administered at meal times and the fourth at bedtime.

⚠️ Warnings 23 words ▾

WARNINGS Patients to be treated with trihexyphenidyl HCl should have a gonioscope evaluation and close monitoring of intraocular pressures at regular periodic intervals.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Minor side effects, such as dryness of the mouth, blurring of vision, dizziness, mild nausea, or nervousness, will be experienced by 30 to 50 percent of all patients. These sensations, however, are much less troublesome with trihexyphenidyl HCl than with belladonna alkaloids and are usually less disturbing than unalleviated parkinsonism. Such reactions tend to become less pronounced, and even to disappear, as treatment continues.

Even before these reactions have remitted spontaneously, they may often be controlled by careful adjustment of the dosage form, amount of drug, or interval between doses. Isolated instances of suppurative parotitis secondary to excessive dryness of the mouth, skin rashes, dilatation of the colon, paralytic ileus, and certain psychiatric manifestations such as delusions and hallucinations, plus one doubtful case of paranoia all of which may occur with any of the atropine-like drugs, have been rarely reported with trihexyphenidyl hydrochloride.

Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Such patients should be allowed to develop a tolerance through the initial administration of a small dose and gradual increase in dose until an effective level is reached. If a severe reaction should occur, administration of the drug should be discontinued for a few days and then resumed at a lower dosage.

Psychiatric disturbances can result from indiscriminate use (leading to overdosage) to sustain continued euphoria. Potential side effects associated with the use of any atropine-like drugs include constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intraocular tension, weakness, vomiting, and headache. The occurrence of angle-closure glaucoma due to long-term treatment with trihexyphenidyl hydrochloride has been reported.

To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

🧬 Clinical Pharmacology 73 words ▾

CLINICAL PHARMACOLOGY Trihexyphenidyl HCl is the substituted piperidine salt, 3-(1-piperidyl)-1-phenylcyclohexyl-1-propanol hydrochloride, which exerts a direct inhibitory effect upon the parasympathetic nervous system. It also has a relaxing effect on smooth musculature; exerted both directly upon the muscle tissue itself and indirectly through an inhibitory effect upon the parasympathetic nervous system. Its therapeutic properties are similar to those of atropine, although undesirable side effects are ordinarily less frequent and severe than with the latter.

📦 How Supplied / Storage and Handling 103 words ▾

HOW SUPPLIED Trihexyphenidyl hydrochloride tablets USP, 2 mg are scored, round, white, flat faced, tablets imprinted DAN DAN and 5335 supplied in bottles of 100 (NDC 0591-5335-01) and 1000 (NDC 0591-5335-10). Trihexyphenidyl hydrochloride tablets USP, 5 mg are scored, round, white, tablets imprinted DAN DAN and 5337 supplied in bottles of 100 (NDC 0591-5337-01) and 1000 (NDC 0591-5337-10). Dispense in a tight container with child-resistant closure.

Store at 20° to 25° (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 2/2024

📋 Description 69 words ▾

DESCRIPTION Trihexyphenidyl hydrochloride is a synthetic antispasmodic drug available in the following forms: Tablets, 2 mg and 5 mg. It is designated chemically 1-Piperidinepropanol,α-cyclohexyl-α-phenyl-, hydrochloride. The structural formula is represented below: C 20 H 31 NO•HCl M.W.

337.93 Trihexyphenidyl hydrochloride tablets USP, 2 mg and 5 mg contain the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. 7066154a-figure-01

⚠️ Precautions 203 words ▾

PRECAUTIONS Although trihexyphenidyl HCl is not contraindicated for patients with cardiac, liver, or kidney disorders, or with hypertension, such patients should be maintained under close observation. Since the use of trihexyphenidyl HCl may, in some cases, continue indefinitely and since it has atropine-like properties, patients should be subjected to constant and careful long-term observation to avoid allergic and other untoward reactions. In as much as trihexyphenidyl HCl possesses some parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy.

Geriatric patients, particularly over the age of 60, frequently develop increased sensitivity to the actions of drugs of this type, and hence, require strict dosage regulation. Incipient glaucoma may be precipitated by parasympatholytic drugs such as trihexyphenidyl HCl. Tardive dyskinesia may appear in some patients on long term therapy with antipsychotic drugs or may occur after therapy when these drugs have been discontinued.

Antiparkinson agents do not alleviate the symptoms of tardive dyskinesia and in some instances may aggravate them. However, parkinsonism and tardive dyskinesia often coexist in patients receiving chronic neuroleptic treatment, and anticholinergic therapy with trihexyphenidyl hydrochloride may relieve some of these parkinsonism symptoms.

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL NDC 0591-5335-01 Trihexyphenidyl Hydrochloride Tablets, USP 2 mg Rx only 100 Tablets tri

PRINCIPAL DISPLAY PANEL NDC 0591-5337-01 Trihexyphenidyl Hydrochloride Tablets, USP 5 mg Rx only 100 Tablets tri

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets00591-5337-01 16,151 Rx · $255,968
1000 tablets00591-5337-10 3,169 Rx · $39,672
33000 tablets00591-5337-00 No Medicaid data
40008 tablets this page00591-5337-77 No Medicaid data
Drug total (last 4 qtrs): 19,320 Rx · 1,299,284 units · $295,640 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for TRIHEXYPHENIDYL HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Drug Interaction63
Nausea52
Coma50
Fall48
Ischaemic Stroke42
Respiratory Distress41
Condition Aggravated38

Age at onset

Child2
Adolescent3
Adult138
Elderly55

Reporter sex

995 reports
Male · 57%
Female · 43%

Serious outcomes

Hospitalization513
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 153 52
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 "Drug For Further Processing". 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 Actavis Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 100 tablets (00591-5337-01), 1000 tablets (00591-5337-10), 33000 tablets (00591-5337-00). 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?
Actavis Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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.
← 00591-5335-01 · Actavis 00591-5347-01 · Actavis →
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.