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Nicardipine Hydrochloride in Sodium Chloride .1 mg/mL Injection, Solution — NDC 44567-850-12 (Billing 44567-0850-12)

by WG Critical Care, LLC · 12 BAG in 1 CARTON / 200 mL in 1 BAG

This is a package of Nicardipine Hydrochloride in Sodium Chloride .1 mg/mL Injection, Solution from WG Critical Care, LLC, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 44567-0850-12
🏷️ FDA NDC (as labeled) 44567-850-12 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 44567-850-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
44567 labeler · 850 product · 12 package
Package marketed since
Jul 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4456785012 9
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Nicardipine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0813-2026
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0802-2026
Class II · Apr 18, 2025 — Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. (American Regent, Inc.) · FDA recall D-0398-2025
Class II · Apr 18, 2025 — Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. (American Regent, Inc.) · FDA recall D-0399-2025
Class II · Feb 20, 2024 — Failed Impurities/Degradation Specifications: Out of specification for organic impurities (Eugia US LLC) · FDA recall D-0391-2024
Class II · Feb 20, 2024 — Failed Impurities/Degradation Specifications: Out of specification for organic impurities (Eugia US LLC) · FDA recall D-0390-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44567-850-12
Product NDC 44567-850
11-digit billing NDC 44567085012
NCPDP billing unit ML — per mL (volume)
Application # ANDA203978
SPL Set ID e1b14bfc-7eb1-4cc1-87fa-21f7e828cb85
Established class (EPC) Dihydropyridine Calcium Channel Blocker; Dihydropyridines [CS
Mechanism of action Calcium Channel Antagonists; Cytochrome P450 2C19 Inhibitors; Cytochrome P450 2C8 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A4 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-10
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance NICARDIPINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 064304
GCN 12735
HICL code 035779
Ingredient (HICL) Nicardipine In Nacl, Iso-Osm
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A9
Therapeutic class — intermediate (HIC2) Calcium Antagonists
HIC3 code A9A
Therapeutic class — specific (HIC3) Calcium Channel Blocking Agents
AHFS code 24:12.92.00
AHFS class Vasodilating Agents, Miscellaneous
FDB label name NICARDIPINE 20 MG/200 ML-NACL
FDB brand name Nicardipine Hcl-Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064304
  • GCN: 12735
  • HICL (First Databank): 035779
  • AHFS class code: 24:12.92.00
Why two NDCs? The FDA registers this code as 44567-850-12 — 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 → 44567-0850-12. 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.

Clinical

Label name NICARDIPINE 20 MG/200 ML-NACL Ingredient Nicardipine In Nacl, Iso-Osm
📗 Our plain-language guide HelloPharmacist
  • Nicardipine treats high blood pressure. The capsules are also used for chronic stable angina, which is chest pain brought on by effort. The IV form is used short term in a medical...
  • You take them by mouth, usually three times a day, and your prescriber adjusts the dose to your blood pressure. Doses shouldn't be raised more often than every 3 days. Food can low...
  • Common ones include ankle swelling, dizziness, headache, flushing, weakness and a pounding heartbeat. These come from the blood vessels widening. Call your doctor if your chest pai...
  • Tell me about everything you take. Nicardipine raises levels of cyclosporine and tacrolimus, and cimetidine raises nicardipine levels. Your doctor may check digoxin levels after yo...
📖 Read our full Nicardipine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
2
Nutrient depletion considerations

Nicardipine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Nicardipine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 mLPer 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.
Medicare Part B allowsASP · J2404 $0.070 / J2404 unit —
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)44567-850-12
11-digit billing NDC44567-0850-12
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2404
DescriptorInjection, nicardipine, 0.1 mg
Billing units / pkg2,400 units
How the units are derivedThis package is 200; the HCPCS unit is 0.1 MG, so one package = 2400 billing units.
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44567-0850-12 You're viewing this Main listing 12 BAG in 1 CARTON / 200 mL in 1 BAG 2025-07-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicardipine Hydrochloride .1 mg/mL 00143-9634-10 Hikma 200 ml — AP FDA listed —
Cardene Iv .1 mg/mL 43066-0009-10 Baxter 200 ml — AP FDA listed —
Cardene IV .1 mg/mL 43066-0021-10 Baxter 200 ml — AP FDA listed —
Cardene Iv .1 mg/mL 43066-0026-10 Baxter 200 ml — AP FDA listed —
Nicardipine Hydrochloride in Sodium Chloride .1 mg/mLthis 44567-0850-12 WG 200 ml — AP FDA listed —
Nicardipine Hydrochloride .1 mg/mL 65145-0197-01 Caplin 1 pouch — AP FDA listed —
Nicardipine Hydrochloride .1 mg/mL 69097-0007-22 Cipla 200 ml — AP FDA listed —
Nicardipine Hydrochloride .1 mg/mL 70069-0875-10 Somerset 10 pouches — AP FDA listed —
Nicardipine Hydrochloride .1 mg/mL 65219-0296-20 Fresenius 200 ml — AP 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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 Nicardipine 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

LabelerWG Critical Care, LLC
Application holderINFORLIFE SA
FDA applicationANDA203978 (ANDA)
Labeler code44567
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio86 products on file

More NDCs from WG Critical Care, LLC labeler code 44567

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.
📄 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. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Nicardipine Hydrochloride — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury114
Hypotension95
Premature Baby95
Foetal Exposure During Pregnancy73
Pyrexia71
Drug Interaction66
Diarrhoea65

Age at onset

Neonate40
Infant1
Child3
Adolescent6
Adult151
Elderly205

Reporter sex

0 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization1,232
Death293
Disabling94
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 88 0
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.

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 ✓ 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 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 WG Critical Care, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WG Critical Care, LLC 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 J2404 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.
← 44567-0845-25 · WG 44567-0851-12 · WG →
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.