What is NDC 80425-0328?

80425-0328 is the product NDC for Dexamethasone, Dexamethasone 4 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dexamethasone?

134 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dexamethasone NDC 80425-0328 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0328Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0328Add 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
80425-0328-1	8042503280180425032801	12 TABLET in 1 BOTTLE (80425-0328-1)Marketed from Apr 24, 2023

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 — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088481
Marketing start: Apr 24, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 80425-0328_2a9bfe6a-6d71-b262-e063-6294a90a1cf3SPL ID 2a9bfe6a-6d71-b262-e063-6294a90a1cf3SPL set ID fa16db27-3c8c-eb22-e053-6394a90add59RxCUI 197582UNII 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

N480425032801 followed by a unit qualifier and the quantity

Package 80425-0328-01. 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 Dec 31, 2024.

Indications (excerpt from the label)

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, seasonal or perennial 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 supplementation is o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0328

What is NDC 80425-0328?: 80425-0328 is the product NDC for Dexamethasone, Dexamethasone 4 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dexamethasone.
What is the active ingredient?: Dexamethasone.
Who is the labeler?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexamethasone?: 134 other product NDCs are listed under this name. See all Dexamethasone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dexamethasone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dexamethasone	Dexamethasone 4 mg/1	TabletOral	Preferred Pharmaceuticals Inc	68788-4113	68788-4113-0168788-4113-0368788-4113-05+1 more
Dexamethasone	Dexamethasone .5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4669	70518-4669-00
Dexamethasone	Dexamethasone .25 mg/1	TabletOral	Pangea Pharmaceuticals, LLC	81279-117	81279-0117-60
Dexamethasone	Dexamethasone .5 mg/5mL	ElixirOral	ANI Pharmaceuticals, Inc.	70954-872	70954-0872-10
Dexamethasone	Dexamethasone 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-534	72789-0534-0172789-0534-2872789-0534-95
Dexamethasone	Dexamethasone .5 mg/5mL	ElixirOral	Bryant Ranch Prepack	72162-2600	72162-2600-02
Dexamethasone	Dexamethasone .5 mg/5mL	ElixirOral	Kanchan Healthcare Inc	85742-004	85742-0004-03
Dexamethasone	Dexamethasone 1.5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3962	68071-3962-03
Dexamethasone	Dexamethasone .5 mg/1	TabletOral	Advagen Pharma Ltd.	72888-235	72888-0235-01
Dexamethasone	Dexamethasone .75 mg/1	TabletOral	Advagen Pharma Ltd.	72888-236	72888-0236-01

All 135 Dexamethasone NDCs

Other NDCs under ANDA 088481

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

FDA NDC Directory listings under ANDA 088481
Product	Strength	Form · route	Labeler	Product NDC
Dexamethasone	Dexamethasone 4 mg/1	TabletOral	Alvogen Inc.	47781-914
Dexamethasone	Dexamethasone 6 mg/1	TabletOral	Alvogen Inc.	47781-916
Dexamethasone	Dexamethasone 4 mg/1	TabletOral	Redpharm Drug, Inc.	67296-1837
Dexamethasone	Dexamethasone 4 mg/1	TabletOral	Proficient Rx LP	71205-703
Dexamethasone	Dexamethasone 4 mg/1	TabletOral	Bryant Ranch Prepack	71335-2108