NDC codes

FDA NDC Directory
Product NDC (as listed)50268-330Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0330Add 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
50268-330-155026803301550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-330-15) / 1 TABLET in 1 BLISTER PACK (50268-330-11)Marketed from Aug 1, 2011

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
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040431
Marketing start
Listing expires
Identifiers
Product ID 50268-330_47e530bb-3b7a-dae5-e063-6394a90a1149SPL ID 47e530bb-3b7a-dae5-e063-6394a90a1149SPL set ID 2cd3965d-cab9-a97c-db61-7d03ced154f3RxCUI 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

N450268033015 followed by a unit qualifier and the quantity

Package 50268-0330-15. 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 AND USAGE Fludrocortisone acetate tablets USP, 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 50268-330

What is NDC 50268-330?
50268-330 is the product NDC for Fludrocortisone Acetate, Fludrocortisone acetate .1 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, 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?
AvPAK, NDC labeler code 50268. 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/1TabletOralMajor Pharmaceuticals0904-731700904-7317-0600904-7317-61
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

All 16 Fludrocortisone Acetate NDCs

Other NDCs under ANDA 040431

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

FDA NDC Directory listings under ANDA 040431
ProductStrengthForm · routeLabelerProduct NDC
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralAmneal Pharmaceuticals of New York LLC0115-7033
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-6562
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralAvKARE42291-764
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralCardinal Health 107, LLC55154-6645
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralAmerican Health Packaging68084-288
Fludrocortisone AcetateFludrocortisone acetate .1 mg/1TabletOralAmneal Pharmaceuticals NY LLC69238-7033

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