Prescription drug · ANDA
Proctosol-HC (Hydrocortisone) NDC 10631-407
Hydrocortisone 25 mg/g · Cream · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10631-407-01 | 1063104070110631040701 | 1 TUBE in 1 CARTON (10631-407-01) / 28.35 g in 1 TUBEMarketed from Apr 28, 2005 |
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)
- Proctosol-HC
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 10631
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088799
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 10631-407_38f87659-b6da-4111-e063-6294a90a522dSPL ID 38f87659-b6da-4111-e063-6294a90a522dSPL set ID 565284e7-4994-486b-8267-18bd166655acRxCUI 310891, 1540356UNII 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
N410631040701followed by a unit qualifier and the quantityPackage 10631-0407-01. 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 relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
About NDC 10631-407
- What is NDC 10631-407?
- 10631-407 is the product NDC for Proctosol-HC (hydrocortisone), Hydrocortisone 25 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Proctosol-HC (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 10631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Proctosol-HC?
- 1 other product NDC are listed under this name. See all Proctosol-HC NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Proctosol-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) |
|---|---|---|---|---|---|
| Proctosol-HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2165 | 72162-2165-02 |
Other NDCs under ANDA 088799
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 | Sun Pharmaceutical Industries, Inc. | 51672-3003 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | DIRECT RX | 61919-364 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-2233 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8583 |
| Proctosol-HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2165 |