Prescription drug · ANDA
Hydrocortisone NDC 68788-8455
Hydrocortisone 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8455-3 | 68788845503 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-8455-3)Marketed from Jun 5, 2023 | |
| 68788-8455-6 | 68788845506 | 60 TABLET in 1 BOTTLE, PLASTIC (68788-8455-6)Marketed from Jun 5, 2023 | |
| 68788-8455-9 | 68788845509 | 90 TABLET in 1 BOTTLE, PLASTIC (68788-8455-9)Marketed from Jun 5, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 68788-8455_bf9c4a2a-ffb9-4e3c-b01f-43c9de68e985SPL ID bf9c4a2a-ffb9-4e3c-b01f-43c9de68e985SPL set ID 0bbb8a63-ae1d-41d7-b201-d1b171b31f46RxCUI 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
N468788845503followed by a unit qualifier and the quantityPackage 68788-8455-03. 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 | AvPAK | 50268-405 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | AvPAK | 50268-406 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | AvPAK | 50268-407 |