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Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution — NDC 25021-0052-05 package photo

Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution

by Sagent Pharmaceuticals · 25 VIAL in 1 CARTON (25021-052-05) / 5 mL in 1 VIAL
NDC 25021-0052-05
🏷️ FDA NDC (as labeled) 25021-052-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 vial Cost per mL$0.2381 NADAC Per package$29.76 / 125 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $6.40/unit — full pricing hub ↓
Also comes in: 25 vials 25021-0052-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 3, 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

⚠️
Other active recalls for Dexamethasone Sodium Phosphate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 4, 2026 — Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. (SOMERSET THERAPEUTICS LLC) · FDA recall D-0398-2026
Class II · May 23, 2024 — Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. (Eugia US LLC) · FDA recall D-0555-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 25021-052-05
Product NDC 25021-052
11-digit billing NDC 25021005205
NCPDP billing unit ML — per mL (volume)
RxCUI 1116927, 1812079, 1812194
UNII AI9376Y64P
Application # ANDA215654
SPL Set ID 4680d517-ed5a-4137-819c-122ee962a464
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-01
Route INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Dosage form INJECTION, SOLUTION
Substance DEXAMETHASONE SODIUM PHOSPHATE
GCN Seq No 006778
GCN 27354
HICL code 002888
Ingredient (HICL) Dexamethasone Sodium Phosphate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P5
Therapeutic class — intermediate (HIC2) Adrenocortical Hormones
HIC3 code P5A
Therapeutic class — specific (HIC3) Glucocorticoids
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name DEXAMETHASONE 20 MG/5 ML VIAL
FDB brand name Dexamethasone Sodium Phosphate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 25021-052-05 — 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 → 25021-0052-05. 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.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSagent Pharmaceuticals
Application holderGLAND PHARMA LTD
FDA applicationANDA215654 (ANDA)
Labeler code25021
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio209 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 DEXAMETHASONE 20 MG/5 ML VIAL Ingredient Dexamethasone Sodium Phosphate
📗 Our plain-language guide HelloPharmacist
  • You're right that it treats a lot of conditions, and that can feel confusing. Dexamethasone is a corticosteroid, which is a type of anti-inflammatory medicine. Whether it's calming...
  • Why has my doctor prescribed dexamethasone — it seems to be used for so many different things?
  • Please don't stop it abruptly without talking to your doctor first, especially if you've been on it for more than a few days. Your body adjusts to having this medication on board,...
  • Can I just stop taking dexamethasone if I feel better or if I'm worried about side effects?
📖 Read our full Dexamethasone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dexamethasone 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.

🧪 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 RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII VTK01UQK3G
    Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.238 $29.76 / 125 ml
Medicaid paysCMS SDUD · 12 mo $6.40 $800.28 / 125 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1100 $0.085 / J1100 unit —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Jan 2026 Feb 2026 Mar 2026 $0.238 $0.200
▲ Up 19% over the last 4 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)25021-052-05
11-digit billing NDC25021-0052-05
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1100
DescriptorINJECTION, DEXAMETHASONE SODIUM PHOSPHATE, 1 MG
Billing units / pkg4 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
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0418-05 Mylan 25 vials $0.238 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mLthis 25021-0052-05 Sagent 25 vials $0.238 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0422-54 Mylan 25 vials $0.238 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0419-01 Mylan 25 vials $0.672 AP Availability likely +182%
Dexamethasone Sodium Phosphate 4 mg/mL 00641-6145-25 Hikma 25 vials $0.672 AP Availability likely +182%
Dexamethasone Sodium Phosphate 4 mg/mL 72572-0120-25 Civica, 25 vials $0.672 AP Availability likely +182%
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0423-12 Mylan 25 vials $0.672 AP Availability likely +182%
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0077-01 Asclemed 1 ml — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0185-01 Asclemed 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7021-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7092-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7128-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7147-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7153-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7157-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7164-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7171-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0555-01 Asclemed 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 84549-0422-54 ProPharma 5 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1451-05 Amneal 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76045-0106-10 Fresenius 1 syringe — AP Discontinued —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1660-03 HF 10 pouches — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0238-05 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 68083-0474-25 Gland 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0398-30 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0239-30 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0421-30 Mylan 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0396-01 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0397-05 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-3300-00 A-S 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0484-30 Mylan 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0023-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7347-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-1922-00 A-S 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1432-01 HF 30 ml — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0237-01 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 68083-0473-25 Gland 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70518-3724-00 REMEDYREPACK 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0024-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76045-0210-10 Fresenius 1 syringe — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00641-6146-25 Hikma 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 84549-0421-30 ProPharma 30 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0022-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1450-05 Amneal 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-2313-02 A-S 2 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1297-01 HF 5 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1452-01 Amneal 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00404-9795-30 Henry 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00404-9805-05 Henry 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70518-4372-00 REMEDYREPACK 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0215-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0217-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0216-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 87063-0289-10 ASCLEMED 10 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 87063-0290-25 ASCLEMED 25 vials — 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

🗺️ 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 25021-0052-05, 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 – Q4 2025 · 4 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
2.5K
Units reimbursed last 4 qtrs
13.8K
Gross reimbursed last 4 qtrs
$88.2K
Avg / prescription
$35.60
Avg / unit
$6.4022
Latest quarter Q4 2025
585Rx
Medicaid pays / mL
$6.4022
gross reimbursed
vs
NADAC / mL
$0.2381
acquisition cost
=
Spread
+$6.1641
+2589% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
93% MCO
Fee-for-service · 162 Rx Managed care · 2,315 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 101 units · 5.1 per 100k residents 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: 451 units · 2.3 per 100k residents 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: 101 units · 3.1 per 100k residents IA Illinois: 59 units · 0.5 per 100k residents IL Indiana: no data reported IN Ohio: 330 units · 2.8 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 60 units · 0.6 per 100k residents NJ Massachusetts: 1,746 units · 24.9 per 100k residents MA California: 5,664 units · 14.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 35 units · 0.6 per 100k residents MO Kentucky: 548 units · 12.1 per 100k residents 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: 99 units · 1.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 25 units · 0.6 per 100k residents OK Louisiana: 704 units · 15.4 per 100k residents LA Mississippi: 473 units · 16.1 per 100k residents MS Alabama: no data reported AL Georgia: 28 units · 0.3 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 30 units · 0.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.124.9
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 24.9 /100k
2 Mississippi 16.1 /100k
3 Louisiana 15.4 /100k
4 California 14.5 /100k
5 Kentucky 12.1 /100k
6 Idaho 5.1 /100k
7 Iowa 3.1 /100k
8 Ohio 2.8 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
25 vials25021-0052-01 7,657 Rx · $509,424
25 vials this page25021-0052-05 2,477 Rx · $88,185
Drug total (last 4 qtrs): 10,134 Rx · 29,422 units · $597,608 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Dexamethasone Sodium Phosphate — the program that covers self-administered drugs. 11 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 Dexamethasone Sodium Phosphate. 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
$780.5K
Claims incl. refills
22.5K
Beneficiaries
17.3K
Spend / beneficiary
$45.01
Spend / claim
$34.65
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 DEXAMETHASONE SODIUM PHOSPHATE — the ingredient across all brands.

Top reported reactions

Nausea604
Pyrexia604
Anaemia495
Diarrhoea470
Platelet Count Decreased447
Myelosuppression440
Neutrophil Count Decreased439

Age at onset

Neonate15
Infant10
Child75
Adolescent40
Adult1,370
Elderly1,101

Reporter sex

0 reports
Male · 50%
Female · 49%
Unknown · 0%

Serious outcomes

Hospitalization4,574
Death1,762
Life-threatening1,212
Disabling361
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,299 452
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 NDCDescription Per unit Per pack Marketing startStatus
25021-0052-01 25 VIAL in 1 CARTON (25021-052-01) / 1 mL in 1 VIAL $0.6719 / mL $16.80 2024-12-01 Active
25021-0052-05 You're viewing this 25 VIAL in 1 CARTON (25021-052-05) / 5 mL in 1 VIAL $0.2381 / mL $29.77 2024-12-01 Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.2381 NADAC).

This pack accounts for about 24% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 25021-0052-05?
NDC 25021-0052-05 is listed by the FDA — 25 vial in 1 carton / 5 ml in 1 vial.
What NDC number is used to bill for this package of Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution?
Bill NDC 25021-0052-05 — the 11-digit billing format is 25021005205. 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.

📄 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE A. Intravenous or Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).

Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.

Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.

2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis. Synovitis of osteoarthritis.

Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis.

Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis.

Ankylosing spondylitis. 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus.

Acute rheumatic carditis. 4. Dermatologic Diseases Pemphigus.

Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis.

Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides.

5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma. Contact dermatitis.

Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis.

Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice).

6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye, such as: Herpes zoster ophthalmicus. Iritis, iridocyclitis.

Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis.

Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis.

Allergic corneal marginal ulcers. Keratitis. 7.

Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8.

Respiratory Diseases Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy.

Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9.

Hematologic Disorders Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated). Secondary thrombocytopenia in adults.

Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10.

Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults. Acute leukemia of childhood. 11.

Edematous States To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Nervous System Acute exacerbations of multiple sclerosis.

13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involv…

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION A. Intravenous or Intramuscular Administration The initial dosage of dexamethasone sodium phosphate injection may vary from 0.50 mg/day to 9.0 mg/day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required.

Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. However, in certain overwhelming, acute, life-threatening situations, administration of dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. For the treatment of unresponsive shock high pharmacologic doses of this product are currently recommended.

Reported regimens range from 1 to 6 mg/kg of body weight as a single intravenous injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists. For the treatment of cerebral edema in adults an initial intravenous dose of 10 mg is recommended followed by 4 mg intramuscularly every six hours until maximum response has been noted. This regimen may be continued for several days postoperatively in patients requiring brain surgery.

Oral dexamethasone, 1 to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a period of five to seven days. Nonoperative cases may require continuous therapy to remain free of symptoms of increased intracranial pressure. The smallest effective dose should be used in children, preferably orally.

This may approximate 0.2 mg/kg/24 hours in divided doses. In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for 1 month have been shown to be effective. The initial dosage should be maintained or adjusted until a satisfactory response is noted.

If after a reasonable period of time there is a lack of satisfactory clinical response, dexamethasone sodium phosphate injection should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.

It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this later situation it may be necessary to increase the dosage of dexamethasone sodium phosphate injection for a period of time consistent with the patient's condition.

If after a long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. B. Intra-Articular, Soft Tissue or Intralesional Administration.

The dose for intrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg.

A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure. Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites.

It should be remembered that corticoids provide palliation only and that other conventional or c…

⛔ Contraindications 4 words ▾

CONTRAINDICATIONS Systemic fungal infections.

⚠️ Warnings ~2 min read ▾

WARNINGS Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy.

The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Immunosuppression and Increased Risk of Infection Corticosteroids, including dexamethasone sodium phosphate injection, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider dexamethasone sodium phosphate injection withdrawal or dosage reduction as needed. Do not administer dexamethasone sodium phosphate injection by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.

Tuberculosis If dexamethasone sodium phosphate injection is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of the disease may occur. Closely monitor such patients for reactivation. During prolonged dexamethasone sodium phosphate injection therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including dexamethasone sodium phosphate injection. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If a dexamethasone sodium phosphate-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If varicella develops, treatment with antiviral agents may be considered.

If a dexamethasone sodium phosphate-treated patient is exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including dexamethasone sodium phosphate injection. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with dexamethasone sodium phosphate injection. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteroids, including dexamethasone sodium phosphate injection, may exacerbate systemic fungal infections; therefore, avoid dexamethasone sodium phosphate injection use in the pres…

🤒 Adverse Reactions ~1 min read ▾

Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy.

The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

ADVERSE REACTIONS Fluid and electrolyte disturbances: Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal: Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal: Peptic ulcer with possible subsequent perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Dermatological: Impaired wound healing Thin fragile skin Facial erythema Increased sweating May suppress reactions to skin tests Petechiae and ecchymoses Neurological: Convulsions Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Vertigo Headache Ophthalmic: Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Endocrine: Menstrual irregularities Development of cushingoid state Suppression of growth in children Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Metabolic: Negative nitrogen balance due to protein catabolism Miscellaneous: Hyperpigmentation or hypopigmentation Subcutaneous and cutaneous atrophy Sterile abscess Post-injection flare, following intra-articular use Charcot-like arthropathy Itching, burning, tingling in the ano-genital region To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy ~1 min read ▾

Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.

These effects are less likely to occur with the synthetic derivatives except when used in large doses. Patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. Dietary salt restriction and potassium supplementation may be necessary.

All corticosteroids increase calcium excretion. While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.

Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug. Dexamethasone sodium phosphate injection, 4 mg per mL contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

🧬 Clinical Pharmacology 55 words ▾

CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

📦 How Supplied / Storage and Handling 143 words ▾

HOW SUPPLIED Dexamethasone Sodium Phosphate Injection USP, is a sterile, clear colorless to almost colorless solution free from foreign visible particles is supplied as: NDC Dexamethasone Sodium Phosphate Injection USP Package Factor (4 mg per mL) 25021-052-01 4 mg per mL Single-Dose Vial 25 vials per carton 25021-052-05 20 mg per 5 mL Multi-Dose Vial 25 vials per carton NDC Dexamethasone Sodium Phosphate Injection USP Package Factor (Preservative Free) 25021-053-01 10 mg per mL Single-Dose Vial 25 vials per carton Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Retain in carton until time of use. Single dose vials - Discard unused portion. Sterile, Nonpyrogenic.

The container closure is not made with natural rubber latex. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in India ©2025 Sagent Pharmaceuticals Revised: July 2025

📦 Storage and Handling 63 words ▾

Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Single dose vials - Discard unused portion. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in India ©2025 Sagent Pharmaceuticals Revised: July 2025

📋 Description 209 words ▾

DESCRIPTION Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP C 22 H 28 FNa 2 O 8 P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt. It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5.

It has the following structural formula: Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations. Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5.

Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL ( Preservative Free ) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Figure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 25021-0009-05 · Sagent 25021-0053-01 · Sagent →
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.