Prescription drug · ANDA
Hydrocortisone NDC 61919-364
Hydrocortisone 25 mg/g · Cream · Topical · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-364-28 | 61919036428 | 28 g in 1 TUBE (61919-364-28)Marketed from Jan 1, 2014 | |
| 61919-364-30 | 61919036430 | 30 g in 1 TUBE (61919-364-30)Marketed from Jan 1, 2015 |
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 — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- DIRECT RX
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088799
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 61919-364_4c493737-c816-c313-e063-6394a90aa366SPL ID 4c493737-c816-c313-e063-6394a90aa366SPL set ID 3d017594-3a00-40ba-b392-1699992fa1b1RxCUI 310891UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461919036428followed by a unit qualifier and the quantityPackage 61919-0364-28. 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 Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 088799
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 25 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-2233 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8583 |
| Proctosol-HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2165 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-3003 |
| Proctosol-HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 10631-407 |