MONTELUKAST SODIUM 10 mg Tablet, 90-count
by REMEDYREPACK INC. · 90 TABLET in 1 BOTTLE, PLASTIC (70518-4753-0)
NDC 70518-4753-00
🏷️ FDA NDC (as labeled)
70518-4753-0
billing pads the package segment with a zero
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Sep 17, 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)
70518-4753-0
Product NDC
70518-4753
11-digit billing NDC
70518475300
Application #
ANDA209012
SPL Set ID
97885c02-badd-4e9a-a680-3754ae1efe55
Established class (EPC)
Leukotriene Receptor Antagonist
Mechanism of action
Leukotriene Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-09-14
Route
ORAL
Dosage form
TABLET
Substance
MONTELUKAST SODIUM
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 70518-4753-0 — 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 → 70518-4753-00. 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
LabelerREMEDYREPACK INC.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA209012 (ANDA)
Labeler code70518
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio1,511 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.
💊 What it looks like
Color
yellow
ShapeRound
Imprint225
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
-
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
-
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
-
UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
-
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 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 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.
💲 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.Reddy's | 100 tablets | — | AB | 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 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 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 65862-0574-10 | Aurobindo | 10 tablets | — | AB | Discontinued | — |
| 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 mgthis 70518-4753-00 | REMEDYREPACK | 90 tablets | — | 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
🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Montelukast Sodium — 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. 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 |
|---|---|---|---|
| 70518-4753-00 You're viewing this | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4753-0) | 2026-09-14 | Active |
🧭 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 FDA registers it as 70518-4753-0, 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: 70518-4753-00, written without dashes as 70518475300. 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 70518-4753-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (4753) 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 REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK 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.
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.
📄 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.
📄 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.