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Dexamethasone Sodium Phosphate 10 mg/mL Injection, Solution, 25 vials

by Amneal Pharmaceuticals LLC · 25 VIAL in 1 CARTON (70121-1399-5) / 1 mL in 1 VIAL (70121-1399-1)
NDC 70121-1399-05
🏷️ FDA NDC (as labeled) 70121-1399-5 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 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) 70121-1399-5
Product NDC 70121-1399
11-digit billing NDC 70121139905
NCPDP billing unit ML — per mL (volume)
RxCUI 1812079
UNII AI9376Y64P
Application # ANDA208690
SPL Set ID ba18ba23-9ea3-4ce1-84ae-74e9151bb6a4
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 2018-08-26
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXAMETHASONE SODIUM PHOSPHATE
GPI-14 22100020202011
GPI class Dexamethasone Sod Phosphate PF
GCN Seq No 062053
GCN 97837
HICL code 034381
Ingredient (HICL) Dexamethasone Sodium Phosp/Pf
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 10 MG/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 70121-1399-5 — a 5-4-1 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 package segment → 70121-1399-05. 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL EU LTD
FDA applicationANDA208690 (ANDA)
Labeler code70121
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio467 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 10 MG/ML VIAL Ingredient Dexamethasone Sodium Phosp/Pf
📗 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 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.
  • 24.75 mg / 1 mL UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 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.

4 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $2.52 $62.97 / 25 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 —
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)70121-1399-5
11-digit billing NDC70121-1399-05
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ1100
DescriptorINJECTION, DEXAMETHASONE SODIUM PHOSPHATE, 1 MG
Billing units / pkg10 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 10 mg/mL 70069-0025-10 Somerset 10 vials $0.504 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 63323-0516-10 Fresenius 10 vials $0.504 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 67457-0420-10 Mylan 10 vials $0.504 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 67457-0483-10 Mylan 10 vials $0.504 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 00641-0367-25 Hikma 25 vials $1.236 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 72572-0122-25 Civica, 25 vials $1.236 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 25021-0053-01 Sagent 25 vials $1.293 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 55150-0304-25 Eugia 25 vials $1.293 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 63323-0506-16 Fresenius 25 vials $1.293 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 70069-0021-25 Somerset 25 vials $1.293 AP Availability likely —
Dexamethasone Sodium Phosphate 10 mg/mL 72485-0118-25 Armas 25 vials $1.293 AP Availability likely —
Dexamethasone sodium phosphate 10 mg/mL 42571-0432-79 Micro 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 50090-3541-00 A-S 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 68083-0607-25 Gland 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mLthis 70121-1399-05 Amneal 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 71872-7091-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 80425-0261-01 Advanced 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 85766-0071-01 Sportpharm 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 85766-0186-25 Sportpharm 25 vials — AP FDA listed —
Dmt Suik 10 mg/mL 76420-0270-01 Asclemed 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 51662-1343-01 HF 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 71872-7090-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 71872-7205-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 76045-0212-10 Fresenius 1 syringe — AP FDA listed —
Dmt Suik 10 mg/mL 80425-0556-01 Advanced 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 51662-1391-01 HF 10 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 55154-5118-05 Cardinal 5 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 70518-0532-01 REMEDYREPACK 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 76420-0399-10 Asclemed 10 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 00404-9842-10 Henry 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 76045-0109-10 Fresenius 1 syringe — AP FDA listed —
Dexamethasone Sodium Phosphate 10 mg/mL 85766-0214-10 Sportpharm 10 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

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 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 70121-1399-05, 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
245
Units reimbursed last 4 qtrs
60
Gross reimbursed last 4 qtrs
$151.13
Avg / prescription
$0.62
Avg / unit
$2.5357
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
83% FFS 17% MCO
Fee-for-service · 204 Rx Managed care · 41 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: 22 units · 0.2 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported 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: 26 units · 0.5 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 11 units · 0.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.00.5
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 Alabama 0.5 /100k
2 Ohio 0.2 /100k
3 Texas 0.0 /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.

📊 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 Marketing startStatus
70121-1399-05 You're viewing this 25 VIAL in 1 CARTON (70121-1399-5) / 1 mL in 1 VIAL (70121-1399-1) 2018-08-26 Active

🧭 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) ✓ 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) ✓ 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 FDA registers it as 70121-1399-5, 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: 70121-1399-05, written without dashes as 70121139905. 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 70121-1399-05, the first segment (70121) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (1399) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals 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 J1100 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~2 min read ▾

INDICATIONS 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 in…

⏱️ Dosage and Administration ~2 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 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 mg/kg 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 mg 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. Non-operative 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 mg 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.

⛔ 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. Immunosuppression and Increased Risk of Infection Corticosteroids, including dexamethasone sodium phosphate, 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 withdrawal or dosage reduction as needed.

Tuberculosis If dexamethasone sodium phosphate is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged 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. 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 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 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. 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. 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, may exacerbate systemic fungal infections; therefore, avoid dexamethasone sodium phosphate use in the presence of such infections unless dexamethasone sodium phosphate is needed to control drug reactions.

For patients on chronic dexamethasone sodium phosphate therapy who develop systemic fungal infections, dexamethasone sodium phosphate withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including dexamethasone sodium phosphate, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating dexamethasone sodium phosphate in patients who have spent ti…

🤒 Adverse Reactions 191 words ▾

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 Charcot-like arthropathy Itching, burning, tingling in the ano-genital region To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

📦 How Supplied / Storage and Handling 97 words ▾

HOW SUPPLIED Dexamethasone sodium phosphate injection USP, 10 mg/mL (Preservative Free) is supplied as a clear, colorless solution, in a single-dose vial as follows: 1 mL, Single-Dose Vial: NDC 70121-1399-1 1 mL, 25 Single-Dose Vials in a Carton: NDC 70121-1399-5 Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion.

CAUTION: Federal law prohibits dispensing without a prescription. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.

Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2024-03

📋 Description 132 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, C 22 H 28 FNa 2 O 8 P, has a molecular weight of 516.41 and chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11β,16α). It occurs as a white to off-white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 10.5.

It has the following structural formula: Dexamethasone sodium phosphate injection, USP is available in 10 mg/mL concentration. Each mL of dexamethasone phosphate injection USP, 10 mg/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. 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70121-1398-01 · Amneal 70121-1450-05 · Amneal →
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.