NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7317Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7317Add 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 NDC11-digit (billing)PackageCopy
0904-7317-060090473170650 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 4, 2024
0904-7317-6100904731761100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 4, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215279
Marketing start
Listing expires
Identifiers
Product ID 0904-7317_b450e16e-26ca-424c-8f9f-3ed4ede6f0f1SPL ID b450e16e-26ca-424c-8f9f-3ed4ede6f0f1SPL set ID 933e28ef-05e8-419e-a786-21eab67f33a2RxCUI 313979UNII V47IF0PVH4

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

N400904731706 followed by a unit qualifier and the quantity

Package 00904-7317-06. 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 .

Indications (excerpt from the label)

INDICATIONS & USAGE Fludrocortisone acetate tablets, 0.1 mg 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 0904-7317

What is NDC 0904-7317?
0904-7317 is the product NDC for Fludrocortisone Acetate, Fludrocortisone acetate .1 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
fludrocortisone acetateFludrocortisone acetate .1 mg/1TabletOralEywa Pharma Inc71930-08871930-0088-1271930-0088-52
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralCardinal Health 107, LLC55154-264455154-2644-00
Fludrocortisone acetateFludrocortisone acetate .1 mg/1TabletOralZydus Lifesciences Limited70771-189370771-1893-0170771-1893-05
Fludrocortisone acetateFludrocortisone acetate .1 mg/1TabletOralViona Pharmaceuticals Inc72578-16472578-0164-0172578-0164-05
Fludrocortisone acetateFludrocortisone acetate .1 mg/1TabletOralGolden State Medical Supply, Inc.51407-70551407-0705-01
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralNorthStar Rx LLC72603-17072603-0170-01
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralNovitium Pharma LLC70954-25270954-0252-1070954-0252-2070954-0252-30
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralBryant Ranch Prepack71335-245471335-2454-01
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralAvKARE42291-76442291-0764-01
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralAvPAK50268-33050268-0330-15

All 16 Fludrocortisone Acetate NDCs

Other NDCs under ANDA 215279

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

FDA NDC Directory listings under ANDA 215279
ProductStrengthForm · routeLabelerProduct NDC
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralNorthStar Rx LLC72603-170
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralNovitium Pharma LLC70954-252
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralCardinal Health 107, LLC55154-2644
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralBryant Ranch Prepack71335-2454

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