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Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution — NDC 0143-9525-10 (Billing 00143-9525-10)

by Hikma Pharmaceuticals USA Inc. · 10 POUCH in 1 BAG / 1 BAG in 1 POUCH / 100 mL in 1 BAG

This is a package of Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution from Hikma Pharmaceuticals USA Inc., marketed since Jan 2020 and currently FDA-listed. It is this product's only package size.

NDC 00143-9525-10
🏷️ FDA NDC (as labeled) 0143-9525-10 billing pads the labeler 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 0143-9525-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0143 labeler · 9525 product · 10 package
Package marketed since
Jan 30, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0143952510 3
Medicaid fills, this package
54 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0143-9525-10
Product NDC 0143-9525
11-digit billing NDC 00143952510
NCPDP billing unit ML — per mL (volume)
Application # ANDA206407
SPL Set ID 8a63d5e8-de78-4117-8371-25880eb3eb00
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
Physiologic effect General Anesthesia
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-30
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXMEDETOMIDINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 078788
GCN 45179
HICL code 040230
Ingredient (HICL) Dexmedetomidine In 0.9 % Nacl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 28:24.92.00
AHFS class Anxiolytics,Sedatives,And Hypnotics,Misc
FDB label name DEXMEDETOMIDIN 400MCG/100ML-NS
FDB brand name Dexmedetomidine-0.9% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078788
  • GCN: 45179
  • HICL (First Databank): 040230
  • AHFS class code: 28:24.92.00
Why two NDCs? The FDA registers this code as 0143-9525-10 — a 4-4-2 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 labeler segment → 00143-9525-10. 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 DEXMEDETOMIDIN 400MCG/100ML-NS Ingredient Dexmedetomidine In 0.9 % Nacl
📖 What it is MedlinePlus · NLM

Dexmedetomidine is used to provide short-term sedation (you are relaxed, sleepy or in some cases asleep) for surgical procedures or during mechanical ventilation. Dexmedetomidine is in a class of medications called alpha2 receptor agonists. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Dexmedetomidine is a sedative used in hospital settings. If you're receiving the IV form, it's being used to keep you calm and comfortable — either while you're on a breathing mach...
  • Why am I getting dexmedetomidine — what is it actually used for?
  • Dexmedetomidine causes sedation, but it's different from general anesthesia. Some patients can actually be roused — meaning if someone calls your name or stimulates you, you may op...
  • Will I be completely unconscious, or will I be able to wake up?
📖 Read our full Dexmedetomidine 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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00143-9525-10 You're viewing this Main listing 10 POUCH in 1 BAG / 1 BAG in 1 POUCH / 100 mL in 1 BAG 2020-01-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexmedetomidine Hydrochloride 4 ug/mLthis 00143-9525-10 Hikma 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 400 ug/100mL 00338-9557-12 Baxter 100 ml — AP FDA listed —
Precedex 4 ug/mL 00409-0155-02 Hospira, 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-1174-10 Hospira, 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-1596-01 Hospira, 1 bottle — AP FDA listed —
Precedex 4 ug/mL 00409-1660-10 Hospira, 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-7853-24 Hospira, 24 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 4 ug/mL 00781-3495-95 Sandoz 10 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride 4 ug/mL 25021-0615-50 Sagent 10 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 25021-0617-82 Sagent 100 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 42023-0187-10 Par 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 400 ug/100mL 43066-0557-12 Baxter 100 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 400 ug/100mL 43066-0565-12 Baxter 100 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 43598-0975-58 Dr.Reddy's 10 vials — AP FDA listed —
Dexmedetomidine in Dextrose 4 ug/mL 44567-0603-24 WG 100 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 52536-0126-08 Wilshire 8 bottles — — FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 55150-0297-10 Eugia 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 63323-0671-00 Fresenius 10 bottles — AP Discontinued —
Dexmedetomidine Hydrochloride 4 ug/mL 66794-0235-41 Piramal 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 400 ug/100mL 67457-0925-10 Mylan 10 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0239-10 Gland 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0657-10 Gland 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride in Sodium Chloride 4 ug/mL 68094-0247-10 Precision 10 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1389-07 Amneal 10 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1712-03 Amneal 12 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 71225-0126-04 Slayback 10 vials — — Discontinued —
Dexmedetomidine Hydrochloride 4 ug/mL 72572-0128-08 CIVICA, 8 bottles — — FDA listed —
Dexmedetomidine Hydrochloride in Sodium Chloride 4 ug/mL 68094-0147-20 Precision 20 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1388-08 Amneal 20 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-3301-10 Hospira, 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 72572-0127-10 CIVICA, 10 bottles — — FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 43598-0976-58 Dr.Reddy's 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride in Sodium Chloride 4 ug/mL 68094-0047-10 Precision 10 vials — AP FDA listed —
Precedex 4 ug/mL 00409-4596-20 Hospira, 20 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-7838-24 Hospira, 24 pouches — AP FDA listed —
Precedex 4 ug/mL 00409-7875-12 Hospira, 12 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9198-10 Hikma 250 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 66794-0234-44 Piramal 20 vials — AP FDA listed —
Precedex 4 ug/mL 00409-1434-01 Hospira, 1 bottle — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9526-10 Hikma 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 42023-0186-20 Par 20 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 52536-0125-10 Wilshire 10 bottles — — FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0238-20 Gland 20 vials — AP FDA listed —
Precedex 4 ug/mL 00409-1454-20 Hospira, 20 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-2815-01 Hospira, 1 bottle — 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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 years 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 Dexmedetomidine 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA206407 (ANDA)
Labeler code00143
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio727 products on file

More NDCs from Hikma Pharmaceuticals USA Inc. labeler code 00143

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 ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
54
Units reimbursed last 4 qtrs
54
Latest quarter Q1 2026
15Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 54 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 54 units · 0.8 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.80.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 0.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“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 Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA 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.
← 00143-9519-10 · Hikma 00143-9526-10 · Hikma →
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.