Dexamethasone

Product NDC
54879-003
11-digit product format
548790003
Labeler code
54879
Product ID
54879-003_edabb5da-f601-8bc5-e053-2a95a90a1249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
ELIXIR
Route
ORAL
Labeler
STI Pharma LLC
Application
ANDA084754
Marketing category
ANDA
Marketing start
1976-09-21
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
1 mg/5mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54879-003DDiscontinued by firm2026-07-31
excluded packagepackage54879-00354879-003-08DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084754-001DEXAMETHASONEDEXAMETHASONE0.5MG/5MLELIXIR / ORALAARS, Approved before 1982

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A084754-001AA

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXAMETHASONEDEXAMETHASONEBryant Ranch Prepack075717e3-be2a-4bb3-bead-492761bfb2872026-01-09Warnings, Adverse reactionsExact identifier
DexamethasoneDEXAMETHASONEANI Pharmaceuticals, Inc.5d9b22ca-c619-4ee3-98eb-74544d0d5cb32025-12-04Warnings, Adverse reactionsExact identifier
DexamethasoneDEXAMETHASONEKesin Pharma Corporation43e2a24a-4465-5787-e063-6394a90a0b812025-11-18Warnings, Adverse reactionsExact identifier
DEXAMETHASONEDEXAMETHASONEKanchan Healthcare Inc02f7bf9c-1aa3-4734-8a3e-1f49498055d72025-11-12Warnings, Adverse reactionsExact identifier
DexamethasoneDEXAMETHASONEMarlex Pharmaceuticals, Inc7b51ffce-ec64-4b49-8870-b9666537c5412025-04-22Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS In patients on corticosteroid therapy subjected to 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 elixir, 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 elixir withdrawal or dosage reduction as needed. Tuberculosis If dexamethasone elixir is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.Closely monitor such patients for reactivation. During prolonged dexamethasone elixir 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 elixir. In corticosteroid-treated patients who have not had these diseases or are nonimmune, particular care should be taken to avoid exposure to varicella and measles: If a dexamethasone elixir-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 elixir-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 elixir. 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 immunosuppre...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Fluid and Electrolyte Disturbances: Sodium retention, Fluid retention, Congestive heart failure in susceptible patients, Potassium loss, Hypokalemic alkalosis, and 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, Tendon rupture. Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease, Pancreatitis, Abdominal distention, and Ulcerative esophagitis. Dermatologic: Impaired wound healing, Thin fragile skin, Petechiae and ecchymoses, Erythema, Increased sweating, May suppress reactions to skin tests, Other cutaneous reactions, such as allergic dermatitis, urticaria, and angioneurotic edema. Neurologic: Convulsions, Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, Vertigo, Headache, and Psychic disturbances. 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, and Hirsutism. Ophthalmic: Posterior subcapsular cataracts, Increased intraocular pressure, Glaucoma, and Exophthalmos. Metabolic: Negative nitrogen balance due to protein catabolism Cardiovascular: Myocardial rupture following recent myocardial infarction (see WARNINGS ) Other: Hypersensitivity, Thromboembolism, Weight gain, Increased appetite, Nausea, Malaise, and Hiccups.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54879-003-082025-04-21C16284748780-11030e365-09af-111a-e063-dadaa90a10e2DEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL
54879-003-082024-01-30C16284748780-11030e365-09af-111a-e063-dadaa90a10e2DEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54879-003-08ML - Milliliter54879-003fba2ee89-81c4-4a73-84d1-65c5dd3c14c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DexamethasoneACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
AlcoholINACTIVE INGREDIENT3K9958V90MDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Edetate SodiumINACTIVE INGREDIENTMP1J8420LUDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DEXAMETHASONE ELIXIR [STI PHARMA LLC]3
RaspberryINACTIVE INGREDIENT4N14V5R27WDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
SorbitolINACTIVE INGREDIENT506T60A25RDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE ELIXIR [STI PHARMA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54879-003DEXAMETHASONE ELIXIR [STI PHARMA LLC]9Legacy NDC20250425_320747b3-5cf1-4e0c-b670-c6a9e72a8845.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309686dexAMETHasone 0.5 MG in 5 mL Oral SolutionPSN4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 0.1 MG/ML Oral SolutionSCD4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 0.5 MG per 5 ML Oral SolutionSY4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 1 MG per 10 ML Oral SolutionSY4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54879-003-0854879000308237 mL in 1 BOTTLE, GLASS (54879-003-08) 237 ml1976-09-210000-00-00NoNoCurrent