Prescription drug · ANDA
Fludrocortisone Acetate NDC 0115-7033
Fludrocortisone acetate .1 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-7033-01 | 00115703301 | 100 TABLET in 1 BOTTLE (0115-7033-01)Marketed from Mar 18, 2002 | |
| 0115-7033-02 | 00115703302 | 500 TABLET in 1 BOTTLE (0115-7033-02)Marketed from Mar 18, 2002 | |
| 0115-7033-03 | 00115703303 | 1000 TABLET in 1 BOTTLE (0115-7033-03)Marketed from Mar 18, 2002 |
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
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040431
- Marketing start
- Listing expires
- Identifiers
- Product ID 0115-7033_1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037SPL ID 1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037SPL set ID 4ed382df-f2d5-46a4-a68b-aba807777093RxCUI 313979UNII V47IF0PVH4UPC 0301157033027, 0301157033010
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
N400115703301followed by a unit qualifier and the quantityPackage 00115-7033-01. 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 AND 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.
About NDC 0115-7033
- What is NDC 0115-7033?
- 0115-7033 is the product NDC for Fludrocortisone Acetate, Fludrocortisone acetate .1 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 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?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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.
Related NDCs: other Fludrocortisone Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Viona Pharmaceuticals Inc | 72578-164 | 72578-0164-0172578-0164-05 |
| 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 |
Other NDCs under ANDA 040431
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-6562 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | AvKARE | 42291-764 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | AvPAK | 50268-330 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-6645 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | American Health Packaging | 68084-288 |
| Fludrocortisone Acetate | Fludrocortisone acetate .1 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-7033 |