Prescription drug · ANDA
Proctozone-Hc (Hydrocortisone 2.5%) NDC 64980-324
Hydrocortisone 25 mg/g · Cream · Topical · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-324-30 | 64980032430 | 1 TUBE in 1 CARTON (64980-324-30) / 30 g in 1 TUBEMarketed from Aug 3, 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)
- Proctozone-Hc
- Generic name (nonproprietary)
- hydrocortisone 2.5%
- Active ingredients
- Hydrocortisone — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- 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 64980-324_d929629c-8c27-4e73-a1ae-4e121ad267deSPL ID d929629c-8c27-4e73-a1ae-4e121ad267deSPL set ID fb5746ff-3ff1-4874-a827-4694133641b9RxCUI 310891, 1440936UNII WI4X0X7BPJUPC 0364980324304
- 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
N464980032430followed by a unit qualifier and the quantityPackage 64980-0324-30. 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 64980-324
- What is NDC 64980-324?
- 64980-324 is the product NDC for Proctozone-Hc (hydrocortisone 2.5%), Hydrocortisone 25 mg/g cream, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 | 63629-2396 | 63629-2396-01 |
| 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 | 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 | 63629-2396 |
| Proctozone-Hchydrocortisone 2.5% | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8847 |
| 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 |