Prescription drug · ANDA
Proctozone-Hc (hydrocortisone 2.5%) NDC 63629-8847
Hydrocortisone 25 mg/g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8847-1 | 63629884701 | 1 TUBE in 1 CARTON (63629-8847-1) / 30 g in 1 TUBEMarketed from Aug 3, 2015 |
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)
- Proctozone-Hc
- Generic name (nonproprietary)
- hydrocortisone 2.5%
- Active ingredients
- Hydrocortisone — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040879
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-8847_ab204adf-db9d-4698-8127-1a52a162fe78SPL ID ab204adf-db9d-4698-8127-1a52a162fe78SPL set ID 1cf056c4-01c6-424a-a436-779417eb8244RxCUI 310891, 1440936UNII 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
N463629884701followed by a unit qualifier and the quantityPackage 63629-8847-01. 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 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 040879
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 |
|---|---|---|---|---|
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Preferred Pharmaceuticals, Inc. | 68788-7091 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1805 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2396 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Rising Pharma Holdings, Inc. | 64980-324 |