Levalbuterol Inhalation Solution 0.63 mg/3mL Solution
by NorthStar RxLLC · 5 POUCH in 1 CARTON (16714-095-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
NDC 16714-0095-25
🏷️ FDA NDC (as labeled)
16714-095-25
billing pads the product segment with a zero
Rx only
Generic
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
16714-095-25
Product NDC
16714-095
11-digit billing NDC
16714009525
NCPDP billing unit
ML — per mL (volume)
Application #
ANDA207820
Established class (EPC)
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Jul 2023)
Route
RESPIRATORY (INHALATION)
Dosage form
SOLUTION
Substance
LEVALBUTEROL HYDROCHLORIDE
GCN Seq No
041848
GCN
24540
HICL code
019858
Ingredient (HICL)
Levalbuterol Hcl
HIC1 code
B
Therapeutic class — broad (HIC1)
Respiratory System
HIC2 code
B6
Therapeutic class — intermediate (HIC2)
Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code
B6W
Therapeutic class — specific (HIC3)
Beta-Adrenergic Agents, Inhaled, Short Acting
AHFS code
12:12.08.12
AHFS class
Selective Beta-2-Adrenergic Agonists
FDB label name
LEVALBUTEROL 0.63 MG/3 ML SOL
FDB brand name
Levalbuterol Hcl
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 16714-095-25 — 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 → 16714-0095-25. 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
LabelerNorthStar RxLLC
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA207820 (ANDA)
Labeler code16714
Product typeHuman Prescription Drug
Portfolio308 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
Label name LEVALBUTEROL 0.63 MG/3 ML SOL Ingredient Levalbuterol Hcl
📗 Our plain-language guide HelloPharmacist
- Levalbuterol is a rescue bronchodilator — it's used to quickly open up your airways when they tighten up, like during an asthma attack or a flare of bronchospasm. Xopenex inhalatio...
- The concentrate form has to be diluted with sterile normal saline before you put it in the nebulizer — never use it straight from the vial without diluting first. You then breathe...
- How do I use the nebulizer solution correctly?
- The most common ones are shakiness (tremor), nervousness, a faster heartbeat, headache, and dizziness — especially when you first start using it. These are usually mild and tend to...
Patient education
Supplement & herbal interactions
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 Levalbuterol Inhalation Solution?
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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.258 | $19.38 / 75 ml |
| 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. | |
| Medicare Part B allowsASP · J7614 | $0.075 / J7614 unit | — |
NADAC price history (per mL) — tap or hover for the price & month
▼ Down 22% over the last 12 months.
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.
🧾 Billing & reimbursement
FDA NDC (as labeled)16714-095-25
11-digit billing NDC16714-0095-25
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7614
DescriptorLEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE, 0.5 MG
Billing units / pkg0.42 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levalbuterol .63 mg/3mL 00115-9931-78 | Amneal | 1 pouch | $0.241 | AN | Availability likely | save 7% |
| Levalbuterol .63 mg/3mL 00378-9691-52 | Mylan | 1 pouch | $0.241 | AN | Availability likely | save 7% |
| Levalbuterol .63 mg/3mL 35573-0444-25 | Burel | 25 pouches | $0.241 | AN | Availability likely | save 7% |
| Levalbuterol Inhalation Solution 0.63 mg/3mLthis 16714-0095-25 | NorthStar | 5 pouches | $0.258 | — | Discontinued | — |
| Levalbuterol .63 mg/3mL 65862-0944-24 | Aurobindo | 2 pouches | $0.334 | AN | FDA listed | +29% |
| Levalbuterol .63 mg/3mL 00093-4146-56 | Teva | 6 pouches | $0.344 | AN | Availability likely | +33% |
| Levalbuterol .63 mg/3mL 76204-0800-01 | Ritedose | 30 pouches | $0.344 | AN | Availability likely | +33% |
| Levalbuterol Inhalation Solution .63 mg/3mL 47335-0746-01 | Sun | 5 pouches | — | — | FDA listed | — |
| Levalbuterol .63 mg/3mL 50090-6377-00 | A-S | 1 pouch | — | AN | FDA listed | — |
| Levalbuterol .63 mg/3mL 63187-0953-24 | Proficient | 24 vials | — | AN | FDA listed | — |
| Levalbuterol .63 mg/3mL 72162-2082-02 | Bryant | 1 pouch | — | AN | FDA listed | — |
| Levalbuterol .63 mg/3mL 81894-0102-25 | Luoxin | 5 pouches | — | AN | 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
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 16714-0095-25 You're viewing this | 5 POUCH in 1 CARTON (16714-095-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 2020-05-05 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Finished prescription product
No longer marketed (per FDA listing data)
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| 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) | ✓ Available |
| 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 | ✓ Available |
| 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 full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 16714-095-25, 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: 16714-0095-25, written without dashes as 16714009525. 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 16714-0095-25, the first segment (16714) is the labeler code FDA assigned to NorthStar RxLLC; the middle segment (0095) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
NorthStar RxLLC 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7614 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
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.