Prescription drug · ANDA
Proctozone-Hc (Hydrocortisone 2.5%) NDC 68788-7091
Hydrocortisone 25 mg/g · Cream · Topical · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7091-3 | 6878870910368788709103 | 1 TUBE in 1 CARTON (68788-7091-3) / 30 g in 1 TUBEMarketed from Feb 12, 2018 |
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
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- 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 68788-7091_036df7c5-9f0e-47c5-b88e-2b7fc83166d8SPL ID 036df7c5-9f0e-47c5-b88e-2b7fc83166d8SPL set ID 5f055f94-b213-431b-897e-1c439660f158RxCUI 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
N468788709103followed by a unit qualifier and the quantityPackage 68788-7091-03. 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 68788-7091
- What is NDC 68788-7091?
- 68788-7091 is the product NDC for Proctozone-Hc (hydrocortisone 2.5%), Hydrocortisone 25 mg/g cream, listed with the FDA by Preferred Pharmaceuticals, 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 | 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 | 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 | 63629-2396 |
| 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 | Bryant Ranch Prepack | 72162-1805 |