Dexamethasone NDC 80425-0346

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0346Add 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
80425-0346-1	80425034601	21 TABLET in 1 BOTTLE (80425-0346-1)Marketed from Jul 31, 2023
80425-0346-2	80425034602	27 TABLET in 1 BOTTLE (80425-0346-2)Marketed from Jul 31, 2023
80425-0346-3	80425034603	49 TABLET in 1 BOTTLE (80425-0346-3)Marketed from Jul 31, 2023
80425-0346-4	80425034604	60 TABLET in 1 BOTTLE (80425-0346-4)Marketed from Oct 28, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201270
Marketing start: Jul 31, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 80425-0346_4250a0b0-e539-57c9-e063-6294a90a4b55SPL ID 4250a0b0-e539-57c9-e063-6294a90a4b55SPL set ID 01cfaa3e-5e30-18fa-e063-6394a90a084eRxCUI 197580UNII 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

N480425034601 followed by a unit qualifier and the quantity

Package 80425-0346-01. 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 Oct 29, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE A l l ergic States: Control of severe or incapacitating a llergic 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: Bul l ous 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 minera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201270

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

FDA NDC Directory listings under ANDA 201270
Product	Strength	Form · route	Labeler	Product NDC
Dexamethasone	Dexamethasone 1.5 mg/1	TabletOral	Proficient Rx LP	82804-132
Dexamethasone 1.5 mg	Dexamethasone 1.5 mg/1	TabletOral	Larken Laboratories, Inc.	68047-702
Dexamethasone 1.5 mg	Dexamethasone 1.5 mg/1	TabletOral	Larken Laboratories, Inc.	68047-702
Dexamethasone 1.5 mg	Dexamethasone 1.5 mg/1	TabletOral	Proficient Rx LP	82804-059