Prescription drug · NDA
Cortef (hydrocortisone) NDC 0009-0012
Hydrocortisone 5 mg/1 · Tablet · Oral · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-0012-01 | 00009001201 | 50 TABLET in 1 BOTTLE (0009-0012-01)Marketed from Dec 15, 1952 |
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)
- Cortef
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 008697
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0009-0012_17306ca2-c631-4281-824c-1cb6d63dcac1SPL ID 17306ca2-c631-4281-824c-1cb6d63dcac1SPL set ID 9ce19944-dd88-4a7b-84ca-b07f4ec23badRxCUI 197782, 197783, 197787, 208680, 208712, 208816UNII WI4X0X7BPJUPC 0300090044015, 0300090031015, 0300090012014
- 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
N400009001201followed by a unit qualifier and the quantityPackage 00009-0012-01. 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 CORTEF 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 cases may…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 008697
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 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-028 |
| Cortefhydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0031 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0073 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0074 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0075 |
| Cortefhydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0044 |