What is NDC 72578-164?

72578-164 is the product NDC for Fludrocortisone acetate, Fludrocortisone acetate .1 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fludrocortisone acetate?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fludrocortisone acetate NDC 72578-164

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-164Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0164Add 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
72578-164-01	7257801640172578016401	100 TABLET in 1 BOTTLE (72578-164-01)Marketed from Dec 2, 2024
72578-164-05	7257801640572578016405	500 TABLET in 1 BOTTLE (72578-164-05)Marketed from Dec 2, 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): Fludrocortisone acetate
Generic name (nonproprietary): fludrocortisone acetate
Active ingredients: Fludrocortisone acetate — .1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219251
Marketing start: Dec 2, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 72578-164_4b107dc9-d932-49db-87ed-66df936588d7SPL ID 4b107dc9-d932-49db-87ed-66df936588d7SPL set ID bc92f5c6-3a65-4fab-85b3-fd5b84f917c1RxCUI 313979UNII V47IF0PVH4UPC 0372578164010

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

N472578016401 followed by a unit qualifier and the quantity

Package 72578-0164-01. 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 Jul 13, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-164

What is NDC 72578-164?: 72578-164 is the product NDC for Fludrocortisone acetate, Fludrocortisone acetate .1 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fludrocortisone acetate.
What is the active ingredient?: Fludrocortisone acetate.
Who is the labeler?: Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fludrocortisone acetate?: 15 other product NDCs are listed under this name. See all Fludrocortisone acetate 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 Fludrocortisone acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
fludrocortisone acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Eywa Pharma Inc	71930-088	71930-0088-1271930-0088-52
Fludrocortisone Acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2644	55154-2644-00
Fludrocortisone acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1893	70771-1893-0170771-1893-05
Fludrocortisone acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-705	51407-0705-01
Fludrocortisone Acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Major Pharmaceuticals	0904-7317	00904-7317-0600904-7317-61
Fludrocortisone Acetate	Fludrocortisone acetate .1 mg/1	TabletOral	NorthStar Rx LLC	72603-170	72603-0170-01
Fludrocortisone Acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Novitium Pharma LLC	70954-252	70954-0252-1070954-0252-2070954-0252-30
Fludrocortisone Acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Bryant Ranch Prepack	71335-2454	71335-2454-01
Fludrocortisone Acetate	Fludrocortisone acetate .1 mg/1	TabletOral	AvKARE	42291-764	42291-0764-01
Fludrocortisone Acetate	Fludrocortisone acetate .1 mg/1	TabletOral	AvPAK	50268-330	50268-0330-15

All 16 Fludrocortisone acetate NDCs

Other NDCs under ANDA 219251

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

FDA NDC Directory listings under ANDA 219251
Product	Strength	Form · route	Labeler	Product NDC
Fludrocortisone acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-705
Fludrocortisone acetate	Fludrocortisone acetate .1 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1893