Prescription drug · ANDA
Fludrocortisone Acetate NDC 72603-170
Fludrocortisone acetate .1 mg/1 · Tablet · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-170-01 | 72603017001 | 100 TABLET in 1 BOTTLE (72603-170-01)Marketed from Sep 7, 2023 |
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
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215279
- Marketing start
- Listing expires
- Identifiers
- Product ID 72603-170_04ad6ba3-6782-b5df-e063-6294a90a7e6eSPL ID 04ad6ba3-6782-b5df-e063-6294a90a7e6eSPL set ID 04ad6ba3-6781-b5df-e063-6294a90a7e6eRxCUI 313979UNII V47IF0PVH4UPC 0372603170016
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
N472603017001followed by a unit qualifier and the quantityPackage 72603-0170-01. 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 .
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.
Other NDCs under ANDA 215279
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2644 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2454 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7317 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | Novitium Pharma LLC | 70954-252 |