Prescription drug · ANDA
Hydrocortisone NDC 68788-8583
Hydrocortisone 25 mg/g · Cream · Topical · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8583-2 | 68788858302 | 1 TUBE in 1 CARTON (68788-8583-2) / 28.35 g in 1 TUBEMarketed from Feb 12, 2024 |
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 — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- 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 68788-8583_4dafae7f-7601-4812-a740-81935ae0d1f6SPL ID 4dafae7f-7601-4812-a740-81935ae0d1f6SPL set ID 02ab1006-c7c8-42c9-bda8-62c9d7142521RxCUI 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
N468788858302followed by a unit qualifier and the quantityPackage 68788-8583-02. 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 the 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 | DIRECT RX | 61919-364 |
| 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 |