Dexamethasone NDC 72578-166

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-166Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0166Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
72578-166-01	72578016601	100 TABLET in 1 BOTTLE (72578-166-01)Marketed from May 13, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Dexamethasone
Generic name (nonproprietary): dexamethasone
Active ingredients: Dexamethasone — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Viona Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216284
Marketing start: May 13, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 72578-166_57d9469e-8d0d-4a58-a56c-3c266fe36b74SPL ID 57d9469e-8d0d-4a58-a56c-3c266fe36b74SPL set ID 360d3af0-8f69-4e82-ab5f-1f70cc2025d4RxCUI 197579UNII 7S5I7G3JQL
Pharmacologic class: Corticosteroid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472578016601 followed by a unit qualifier and the quantity

Package 72578-0166-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective May 13, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216284

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216284
Product	Strength	Form · route	Labeler	Product NDC
Dexamethasone	Dexamethasone 1 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1706