Prescription drug · ANDA
Proctozone-Hc (Hydrocortisone 2.5%) NDC 63629-2396
Hydrocortisone 25 mg/g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2396-1 | 63629239601 | 1 TUBE in 1 CARTON (63629-2396-1) / 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 PrepackNDC labeler code 63629
- 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 63629-2396_3283b7d0-17da-43fb-9795-01c22e6ba47eSPL ID 3283b7d0-17da-43fb-9795-01c22e6ba47eSPL set ID bfafb095-6dd1-4a38-88a7-16f6e0aa8de5RxCUI 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
N463629239601followed by a unit qualifier and the quantityPackage 63629-2396-01. 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.
About NDC 63629-2396
- What is NDC 63629-2396?
- 63629-2396 is the product NDC for Proctozone-Hc (hydrocortisone 2.5%), Hydrocortisone 25 mg/g cream, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Proctozone-Hc (Hydrocortisone 2.5%).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Proctozone-Hc?
- 4 other product NDCs are listed under this name. See all Proctozone-Hc NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Proctozone-Hc products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Preferred Pharmaceuticals, Inc. | 68788-7091 | 68788-7091-03 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8847 | 63629-8847-01 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Rising Pharma Holdings, Inc. | 64980-324 | 64980-0324-30 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1805 | 72162-1805-02 |
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 | Bryant Ranch Prepack | 63629-8847 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Rising Pharma Holdings, Inc. | 64980-324 |
| 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 |