Prescription drug · ANDA
Hydrocortisone NDC 50268-406
Hydrocortisone 10 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-406-15 | 50268040615 | 50 BLISTER PACK in 1 BOX (50268-406-15) / 1 TABLET in 1 BLISTER PACK (50268-406-11)Marketed from Jan 31, 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)
- Hydrocortisone
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040646
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50268-406_2b497b3c-577d-f786-e063-6294a90ad095SPL ID 2b497b3c-577d-f786-e063-6294a90ad095SPL set ID f3956208-291c-7374-e053-2a95a90a4628RxCUI 197782, 197783, 197787UNII WI4X0X7BPJ
- Pharmacologic class
- Corticosteroid
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
N450268040615followed by a unit qualifier and the quantityPackage 50268-0406-15. 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 Hydrocortisone Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected c…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040646
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 |
|---|---|---|---|---|
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2018 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7188 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1989 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1696 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1697 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1700 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2044 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8455 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | AvPAK | 50268-405 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | AvPAK | 50268-407 |