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🫁no package photo
in the FDA label

Levalbuterol Inhalation Solution 0.31 mg/3mL Solution

by NorthStar RxLLC · 5 POUCH in 1 CARTON (16714-094-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
NDC 16714-0094-25
🏷️ FDA NDC (as labeled) 16714-094-25 billing pads the product segment with a zero
This package
Contains3 mL in 1 vial, single-dose Cost per mL$0.3478 NADAC Per package$26.09 / 75 ml Pack sizes2 compare ↓
Also comes in: 6 pouches 16714-0094-30
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 16714-094-25
Product NDC 16714-094
11-digit billing NDC 16714009425
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 049871
GCN 15665
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 0.31 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 16714-094-25 — 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 → 16714-0094-25. 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 0.31 MG/3 ML SOL Ingredient Levalbuterol Hcl
📖 What it is MedlinePlus · NLM

Levalbuterol is used to prevent or relieve the wheezing, shortness of breath, coughing, and chest tightness caused by lung disease such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Levalbuterol is in a class of medications called beta agonists. It works by relaxing and opening air passages to the lungs to make breathing easier.

Read the full MedlinePlus article ↗
📗 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...
📖 Read our full Levalbuterol Oral Inhalation 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.348 $26.09 / 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
Jun 2022 $0.348 $0.348
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)16714-094-25
11-digit billing NDC16714-0094-25
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 / pkg0.21 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levalbuterol .31 mg/3mL 00115-9930-78 Amneal 1 pouch $0.266 AN Availability likely save 24%
Levalbuterol .31 mg/3mL 00378-9690-52 Mylan 1 pouch $0.266 AN Availability likely save 24%
Levalbuterol .31 mg/3mL 35573-0443-25 Burel 25 pouches $0.266 AN Availability likely save 24%
Levalbuterol .31 mg/3mL 00093-4145-56 Teva 6 pouches $0.345 AN Availability likely save 1%
Levalbuterol .31 mg/3mL 76204-0700-01 Ritedose 30 pouches $0.345 AN Availability likely save 1%
Levalbuterol Inhalation Solution 0.31 mg/3mLthis 16714-0094-25 NorthStar 5 pouches $0.348 — Discontinued —
Levalbuterol .31 mg/3mL 65862-0943-24 Aurobindo 2 pouches $0.492 AN FDA listed +41%
Levalbuterol Inhalation Solution .31 mg/3mL 47335-0743-01 Sun 5 pouches — — FDA listed —
Levalbuterol .31 mg/3mL 72162-2081-02 Bryant 1 pouch — AN FDA listed —
Levalbuterol .31 mg/3mL 81894-0101-25 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 NDCDescription Per unit Per pack Marketing startStatus
16714-0094-25 You're viewing this 5 POUCH in 1 CARTON (16714-094-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE $0.3478 / mL $26.09 2020-05-05 Discontinued by firm
16714-0094-30 6 POUCH in 1 CARTON (16714-094-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE $0.3374 / mL $30.36 2020-05-05 Discontinued by firm

Per mL, this pack runs about 3% above the cheapest pack (NDC 16714-0094-30, $0.3374 vs $0.3478 NADAC).

Pack size FAQ

What quantity is in NDC 16714-0094-25?
NDC 16714-0094-25 is listed by the FDA — 5 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Levalbuterol Inhalation Solution 0.31 mg/3mL Solution?
Bill NDC 16714-0094-25 — the 11-digit billing format is 16714009425. 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.

🧭 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 The FDA label for this product carries no photos.
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 16714-094-25, 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: 16714-0094-25, written without dashes as 16714009425. 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 16714-0094-25, the first segment (16714) is the labeler code FDA assigned to NorthStar RxLLC; the middle segment (0094) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 6 pouches (16714-0094-30). 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?
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
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 16714-0087-01 · NorthStar 16714-0098-01 · NORTHSTAR →
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.