Prescription drug · ANDA
Procto-Med HC (Hydrocortisone) NDC 69315-312
Hydrocortisone 25 mg/g · Cream · Topical · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-312-28 | 69315031228 | 1 TUBE in 1 CARTON (69315-312-28) / 28 g in 1 TUBEMarketed from Feb 14, 2020 |
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)
- Procto-Med HC
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085025
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69315-312_614fdcc8-43c2-4c42-a7fe-016844f338d8SPL ID 614fdcc8-43c2-4c42-a7fe-016844f338d8SPL set ID 0682580e-aff8-4b67-99ba-a29ab7b433dbRxCUI 310891, 1790684UNII 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
N469315031228followed by a unit qualifier and the quantityPackage 69315-0312-28. 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 dermatosis.
Excerpt only. Read the full label for complete information.
About NDC 69315-312
- What is NDC 69315-312?
- 69315-312 is the product NDC for Procto-Med HC (hydrocortisone), Hydrocortisone 25 mg/g cream, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Procto-Med HC (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Procto-Med HC?
- 1 other product NDC are listed under this name. See all Procto-Med HC NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Procto-Med 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) |
|---|---|---|---|---|---|
| Procto-Med HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-3968 | 68071-3968-01 |
Other NDCs under ANDA 085025
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 | Padagis Israel Pharmaceuticals Ltd | 45802-004 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | A-S Medication Solutions | 50090-0244 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | A-S Medication Solutions | 50090-0350 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8666 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8667 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 66267-967 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Preferred Pharmaceuticals, Inc. | 68788-9922 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-3078 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1382 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Proficient Rx LP | 82804-135 |
| Hydrocortisone Cream | Hydrocortisone 25 mg/g | CreamTopical | Direct_Rx | 72189-554 |
| Procto-Med HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-3968 |