Prescription drug · ANDA
Hydrocortisone NDC 82804-135
Hydrocortisone 25 mg/g · Cream · Topical · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-135-28 | 82804013528 | 1 TUBE in 1 CARTON (82804-135-28) / 28 g in 1 TUBEMarketed from Aug 22, 2024 |
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)
- Hydrocortisone
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-135_e1166b3a-a304-4030-ab51-eb55c6e91afdSPL ID e1166b3a-a304-4030-ab51-eb55c6e91afdSPL set ID e1166b3a-a304-4030-ab51-eb55c6e91afdRxCUI 310891UNII WI4X0X7BPJUPC 0382804135288
- 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
N482804013528followed by a unit qualifier and the quantityPackage 82804-0135-28. 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 82804-135
- What is NDC 82804-135?
- 82804-135 is the product NDC for Hydrocortisone, Hydrocortisone 25 mg/g cream, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone.
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocortisone?
- 169 other product NDCs are listed under this name. See all Hydrocortisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocortisone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocortisone | Hydrocortisone 1 g/100g | LotionTopical | Amazon.com Services LLC | 72288-469 | 72288-0469-25 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-892 | 43547-0892-05 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Solco Healthcare LLC | 43547-893 | 43547-0893-10 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Solco Healthcare LLC | 43547-894 | 43547-0894-10 |
| Hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Amazon.com Services LLC | 72288-713 | 72288-0713-64 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-065 | 21922-0065-0521922-0065-30 |
| Hydrocortisone | Hydrocortisone 20 mg/g | GelTopical | Redmont Pharmaceuticals, LLC | 71741-455 | 71741-0455-31 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Sportpharm LLC | 85766-166 | 85766-0166-1085766-0166-25 |
| hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Sportpharm LLC | 85766-151 | 85766-0151-28 |
| Hydrocortisonehydrocortisone cream 1% | Hydrocortisone 1 g/100g | CreamTopical | Aldermed Inc. | 87236-004 | 87236-0004-09 |
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 | Bryant Ranch Prepack | 63629-8666 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8667 |
| Hydrocortisone Cream | Hydrocortisone 25 mg/g | CreamTopical | Direct_Rx | 72189-554 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Preferred Pharmaceuticals, Inc. | 68788-9922 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | A-S Medication Solutions | 50090-0244 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | A-S Medication Solutions | 50090-0350 |
| Procto-Med HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-3968 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 66267-967 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-3078 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1382 |
| Procto-Med HChydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Leading Pharma, LLC | 69315-312 |