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Mupirocin 20 mg/g Ointment, 20 g — NDC 61919-158-22 (Billing 61919-0158-22)

by DIRECT RX · 20 g in 1 TUBE

This is a package of 20 g of Mupirocin 20 mg/g Ointment from DIRECT RX, marketed since Jan 2014 and currently FDA-listed. It is this product's only package size.

NDC 61919-0158-22
🏷️ FDA NDC (as labeled) 61919-158-22 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 61919-158-22 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61919 labeler · 158 product · 22 package
Package marketed since
Jan 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
20 g per package
Barcode (UPC-A, from the NDC)
3 6191915822 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61919-158-22
Product NDC 61919-158
11-digit billing NDC 61919015822
NCPDP billing unit GM — per gram (weight)
RxCUI 106346
UNII D0GX863OA5
Application # ANDA065085
SPL Set ID f88eea1a-2ba1-48bf-96c8-d96d18752aaa
Established class (EPC) RNA Synthetase Inhibitor Antibacterial
Mechanism of action RNA Synthetase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-01
Route TOPICAL
Dosage form OINTMENT
Substance MUPIROCIN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90100065104210
GPI class Mupirocin
GCN Seq No 007732
GCN 47450
HICL code 003385
Ingredient (HICL) Mupirocin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5W
Therapeutic class — specific (HIC3) Topical Antibiotics
AHFS code 84:04.04.00
AHFS class Antibacterials (84:04)
FDB label name MUPIROCIN 2% OINTMENT
FDB brand name Mupirocin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007732
  • GCN: 47450
  • GPI-14 (Medi-Span): 90100065104210
  • HICL (First Databank): 003385
  • AHFS class code: 84:04.04.00
  • RxCUI (RxNorm): 106346
Why two NDCs? The FDA registers this code as 61919-158-22 — 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 → 61919-0158-22. 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 RNA Synthetase Inhibitor Antibacterial class.

Pharmacologic class RNA Synthetase Inhibitor Antibacterial
Drug family (ATC) Other antibiotics for topical use, Other nasal preparations
How it works RNA Synthetase Inhibitors
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 MUPIROCIN 2% OINTMENT Ingredient Mupirocin
📗 Our plain-language guide HelloPharmacist
  • It treats certain bacterial skin infections. The ointment is for impetigo. The cream is for small infected cuts or wounds. Both target Staphylococcus aureus and Streptococcus pyoge...
  • Put a small amount on the infected area with a cotton swab or gauze, 3 times a day. You can cover it with gauze if you like. Follow your prescriber’s directions for how many days.
  • Check back with your prescriber if you don’t see improvement within 3 to 5 days. Stop and call if you have severe irritation. Get emergency help for hives, swelling or trouble brea...
  • No. It is not for the nose, eyes or other moist body surfaces. If it gets in your eyes, rinse well with water.
📖 Read our full Mupirocin guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Mupirocin — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Mupirocin (3 interactions) — ranked by severity →
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 gPer 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 · Q2 2026 $0.3533 $7.07 / 20 g
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
61919-0158-22 You're viewing this Main listing 20 g in 1 TUBE 2015-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mupirocin 20 mg/g 00093-1010-42 Teva 1 tube $0.146 AB Availability likely —
Mupirocin 20 mg/g 51672-1312-00 Sun 1 tube $0.146 AB Availability likely —
Mupirocin 20 mg/g 68462-0180-22 Glenmark 22 g $0.146 AB Availability likely —
Mupirocin 20 mg/g 21922-0073-04 Encube 1 tube $0.298 AB Availability likely —
mupirocin 20 mg/g 45802-0112-14 Padagis 1 tube $0.298 AB Availability likely —
Mupirocin 20 mg/g 00121-1076-00 PAI 100 tubes — AB FDA listed —
mupirocin 20 mg/g 17856-0112-01 ATLANTIC 1 g — AB FDA listed —
mupirocin 20 mg/g 50090-1587-00 A-S 1 tube — AB FDA listed —
Mupirocin 20 mg/g 50268-0568-15 AvPAK 50 tubes — AB FDA listed —
mupirocin 20 mg/g 60760-0960-22 St. 1 tube — AB FDA listed —
Mupirocin 20 mg/gthis 61919-0158-22 DIRECT 20 g — AB FDA listed —
Mupirocin 20 mg/g 63187-0015-22 Proficient 22 g — AB FDA listed —
Mupirocin 20 mg/g 63187-0151-22 Proficient 1 tube — AB FDA listed —
mupirocin 20 mg/g 63187-0261-22 Proficient 1 tube — AB FDA listed —
Mupirocin 20 mg/g 63187-0525-22 Proficient 1 tube — AB FDA listed —
mupirocin 20 mg/g 63629-8687-01 Bryant 1 tube — AB FDA listed —
Mupirocin 20 mg/g 67296-2211-01 Redpharm 1 tube — AB FDA listed —
Mupirocin 20 mg/g 68071-4111-02 NuCare 22 g — AB FDA listed —
Mupirocin 20 mg/g 68071-4321-02 NuCare 22 g — AB FDA listed —
mupirocin 20 mg/g 68071-4789-02 NuCare 22 g — AB FDA listed —
Mupirocin 20 mg/g 68788-8534-02 Preferred 22 g — AB FDA listed —
mupirocin 20 mg/g 68788-8642-02 Preferred 1 tube — AB FDA listed —
Mupirocin 20 mg/g 70166-0355-10 Lohxa 100 tubes — AB FDA listed —
mupirocin 20 mg/g 70518-1808-00 REMEDYREPACK 1 tube — AB FDA listed —
mupirocin 20 mg/g 71335-2829-01 Bryant 1 tube — AB FDA listed —
mupirocin 20 mg/g 72162-2270-02 Bryant 1 tube — AB FDA listed —
mupirocin 20 mg/g 76420-0128-22 Asclemed 22 g — AB FDA listed —
Mupirocin 20 mg/g 80425-0246-01 Advanced 1 tube — AB FDA listed —
Mupirocin 20 mg/g 80425-0254-01 Advanced 1 tube — AB FDA listed —
Mupirocin 20 mg/g 81033-0032-50 Kesin 50 tubes — AB FDA listed —
Mupirocin 20 mg/g 85766-0207-15 Sportpharm 1 tube — AB FDA listed —
mupirocin 20 mg/g 85534-0038-00 HAWAII 1 tube — AB 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

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 Mupirocin 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

LabelerDIRECT RX
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA065085 (ANDA)
Labeler code61919
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio204 products on file

More NDCs from DIRECT RX labeler code 61919

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

INDICATIONS & USAGE SECTION Mupirocin ointment 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.

⏱️ Dosage and Administration 46 words ▾

DOSAGE & ADMINISTRATION SECTION A small amount of mupirocin ointment should be applied to the affected area three times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be reevaluated.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS SECTION This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

⚠️ Warnings 9 words ▾

WARNINGS SECTION Mupirocin ointment is not for ophthalmic use.

🤒 Adverse Reactions 50 words ▾

ADVERSE REACTIONS SECTION The following local adverse reactions have been reported in connection with the use of mupirocin ointment: burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY SECTION Application of 14C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (< 1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. Following intravenous or oral administration, mupirocin is rapidly metabolized.

The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in seven healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency.

Microbiology Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria.

Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents. Resistance occurs rarely.

However, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC > 1024 mcg/mL) has been reported in some strains of S. aureus and coagulase-negative staphylococci. Mupirocin is bactericidal at concentrations achieved by topical administration.

However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound (> 97%), and the effect of wound secretions on the MICs of mupirocin has not been determined. Mupirocin has been shown to be active against most strains of Staphylococcus aureus and Streptococcus pyogenes, both in vitro and in clinical studies.

(See INDICATIONS AND USAGE.) The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus.

📦 How Supplied / Storage and Handling 56 words ▾

HOW SUPPLIED SECTION Mupirocin Ointment USP, 2% is supplied in 22 gram tubes. Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]. *Bactroban® Nasal is a registered trademark of SmithKline Beecham Pharmaceuticals. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. F 3/2005

📋 Description 58 words ▾

DESCRIPTION SECTION Each gram of Mupirocin Ointment 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β- methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid.

The chemical structure is: C26H44O9 M.W. 500.63 image description

⚠️ Precautions ~2 min read ▾

PRECAUTIONS SECTION If a reaction suggesting sensitivity or chemical irritation should occur with use of mupirocin ointment 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted. As with other antibacterial products prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Mupirocin ointment is not formulated for use on mucosal surfaces.

Intranasal use has been associated with isolated reports of stinging and drying. A paraffin-based formulation – *Bactroban® Nasal (mupirocin calcium ointment) – is available for intranasal use. Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys.

In common with other polyethylene glycol-based ointments, mupirocin ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. Information for Patients Use this medication only as directed by your health provider. It is for external use only.

Avoid contact with the eyes. The medication should be stopped and your health care practitioner contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact your health care practitioner.

Drug Interactions The effect of the concurrent application of mupirocin ointment and other drug products has not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted. Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin. PregnancyTeratogenic EffectsPregnancy category B Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of harm to the fetus due to mupirocin.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when mupirocin ointment is administered to a nursing woman. Pediatric Use The safety and effectiveness of mupirocin ointment have been established in the age range of 2 months to 16 years. Use of mupirocin ointment in these age groups is supported by evidence from adequate and well-controlled studies of mupirocin ointment in impetigo in pediatric patients studied as a part of the pivotal clinical trials (see CLINICAL STUDIES).

🔬 Clinical Studies ~1 min read ▾

CLINICAL STUDIES SECTION The efficacy of topical mupirocin ointment in impetigo was tested in two studies. In the first, patients with impetigo were randomized to receive either mupirocin ointment or vehicle placebo t.i.d. for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for mupirocin ointment (n = 49) and 35% for vehicle placebo (n = 51).

Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment. In the second study, patients with impetigo were randomized to receive either mupirocin ointment t.i.d. or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) for 8 days.

There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric patients included) were 93% for mupirocin ointment (n = 29) and 78.5% for erythromycin (n = 28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups.

There were no side effects reported in the mupirocin ointment group. Pediatrics There were 91 pediatric patients aged 2 months to 15 years in the first study described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n = 42) and 36% for vehicle placebo (n = 49).

In the second study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment. The age range of the pediatric patients was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment (n = 27) was 96%, and for the erythromycin it was unchanged (78.5%).

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 158

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 Mupirocin — the program that covers self-administered drugs. 5 manufacturers.
⚠️ 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 Mupirocin. 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
$9.08M
Claims incl. refills
1.1M
Beneficiaries
906.8K
Spend / beneficiary
$10.01
Spend / claim
$8.55
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
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 — Not published for this NDC No photo available yet for this listing.
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 ✓ 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 DIRECT RX. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DIRECT RX 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.
← 61919-0153-60 · Direct_Rx 61919-0164-21 · DIRECT →
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.