Prescription drug · NDA
Khindivi (Hydrocortisone) NDC 71863-116
Hydrocortisone 1 mg/mL · Solution · Oral · Eton Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71863-116-16 | 7186301161671863011616 | 1 mL in 1 BOTTLE (71863-116-16)Marketed from Jun 2, 2025 |
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)
- Khindivi
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Eton Pharmaceuticals, Inc.NDC labeler code 71863
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218980
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71863-116_4e6ce593-4984-4a6f-e063-6394a90a0169SPL ID 4e6ce593-4984-4a6f-e063-6394a90a0169SPL set ID 1ef80500-8386-40ee-b608-516cd687b376RxCUI 2716550, 2716556UNII WI4X0X7BPJUPC 0371863116161
- 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
N471863011616followed by a unit qualifier and the quantityPackage 71863-0116-16. 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)
KHINDIVI is indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency. KHINDIVI is a corticosteroid indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency. ( 1 ) Limitations of Use KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing [see Warnings and Precautions (5.1) ] . Limitations of Use KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing [(see Warnings and Prec…
Excerpt only. Read the full label for complete information.
About NDC 71863-116
- What is NDC 71863-116?
- 71863-116 is the product NDC for Khindivi (hydrocortisone), Hydrocortisone 1 mg/mL solution, listed with the FDA by Eton Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Khindivi (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Eton Pharmaceuticals, Inc., NDC labeler code 71863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Khindivi?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.