montelukast sodium 10 mg Tablet, Film Coated, 146,300-count
by ORGANON PHARMA (UK) LIMITED · 1 BAG in 1 DRUM (60312-0117-0) / 146300 TABLET, FILM COATED in 1 BAG
NDC 60312-0117-00
🏷️ FDA NDC (as labeled)
60312-0117-0
billing pads the package segment with a zero
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
60312-0117-0
Product NDC
60312-0117
11-digit billing NDC
60312011700
SPL Set ID
16dfa1ce-c7a3-4ee0-afde-2eada1b7642b
DEA schedule
Non-controlled
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1998-02-20
Dosage form
TABLET, FILM COATED
Substance
MONTELUKAST SODIUM
Why two NDCs?
The FDA registers this code as 60312-0117-0 — 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 → 60312-0117-00. 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.
🏭 Manufacturer & labeler
LabelerORGANON PHARMA (UK) LIMITED
Labeler code60312
First marketedFeb 1998
Product typeDrug For Further Processing
Portfolio21 products on file
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.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- It does more than just treat allergies. Montelukast is used to help prevent and control asthma on a daily basis, to prevent breathing problems triggered by exercise, and to relieve...
- What is montelukast actually used for — is it just for allergies?
- This is a real and important concern — the FDA has placed its strongest warning on montelukast because of reported mental health side effects. These can include mood changes, agita...
- I heard montelukast can affect your mood. Should I be worried?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Montelukast Sodium — tap one for details:
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.
💬 Questions about montelukast sodium?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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.
💲 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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Montelukast Sodium 10 mg 13668-0081-05 | Torrent | 500 tablets | $0.042 | AB | Availability likely | — |
| Montelukast Sodium 10 mg 16571-0100-09 | Rising | 90 tablets | $0.042 | AB | Availability likely | — |
| Montelukast Sodium 10 mg 69367-0287-05 | Westminster | 500 tablets | $0.042 | AB | Availability likely | — |
| Montelukast Sodium 10 mg 68084-0875-01 | American | 1 tablet | $0.042 | AB | Availability likely | — |
| Montelukast Sodium 10 mg 00904-6808-06 | Major | 1 tablet | $0.042 | AB | Availability likely | — |
| Montelukast Sodium 10 mg 16729-0119-10 | Accord | 30 tablets | $0.042 | AB | Availability likely | — |
| Singulair 10 mg 78206-0172-01 | Organon | 30 tablets | $9.212 | AB | Availability likely | — |
| Montelukast Sodium 10 mg 63187-0430-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 63187-0692-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Montelukast Sodium 10 mg 63187-0781-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| montelukast sodium 10 mg 71205-0181-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| montelukast sodium 10 mg 29300-0220-01 | Unichem | 100 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 55111-0725-01 | Dr. | 100 tablets | — | — | FDA listed | — |
| Montelukast Sodium 10 mg 71205-0778-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 71335-0514-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 72189-0418-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 65862-0574-10 | Aurobindo | 10 tablets | — | AB | Discontinued | — |
| Montelukast Sodium 10 mg 55154-8075-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 72789-0306-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| montelukast sodium 10 mg 71335-1995-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| montelukast sodium 10 mgthis 60312-0117-00 | ORGANON | 146300 tablets | — | — | FDA listed | — |
| Montelukast Sodium 10 mg 27241-0018-03 | Ajanta | 30 tablets | — | — | FDA listed | — |
| Montelukast Sodium 10 mg 31722-0726-01 | Camber | 100 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 43063-0762-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 57237-0255-30 | Rising | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 68071-4047-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| montelukast sodium 10 mg 68071-5278-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| montelukast sodium 10 mg 68788-8617-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 67296-1926-03 | Redpharm | 30 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 68071-3355-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 68788-8610-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Montelukast 10 mg 50090-6109-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Montelukast Sodium 10 mg 70518-4753-00 | REMEDYREPACK | 90 tablets | — | AB | 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
🏛️
1998
On the market since
Feb 1998
📍
2026
Currently FDA-listed
28 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Montelukast Sodium (matched by generic name) — the program that covers self-administered drugs. 16 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 Montelukast Sodium. CMS lists 2 products for this generic; we show the highest-spend one. 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
$36.74M
Claims incl. refills
3.1M
Beneficiaries
2.3M
Spend / beneficiary
$15.93
Spend / claim
$11.90
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.
🔬 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 Montelukast Sodium — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 28%
Female · 71%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60312-0117-00 You're viewing this | 1 BAG in 1 DRUM (60312-0117-0) / 146300 TABLET, FILM COATED in 1 BAG | — | Active |
🧭 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: ORGANON PHARMA (UK) LIMITED 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 | — 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 | — 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 FDA registers it as 60312-0117-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 60312-0117-00, written without dashes as 60312011700. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 60312-0117-00, the first segment (60312) is the labeler code FDA assigned to ORGANON PHARMA (UK) LIMITED; the middle segment (0117) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 ORGANON PHARMA (UK) LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ORGANON PHARMA (UK) LIMITED 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.
📄 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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.