Prescription drug · ANDA
Hydrocortisone Acetate Cream NDC 28595-050
Hydrocortisone acetate 20 mg/g · Cream · Topical · Allegis Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 28595-050-01 | 2859500500128595005001 | 28.4 g in 1 CARTON (28595-050-01)Marketed from Jul 29, 2026 |
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 Acetate Cream
- Generic name (nonproprietary)
- hydrocortisone acetate cream
- Active ingredients
- Hydrocortisone acetate — 20 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Allegis Pharmaceuticals, Inc.NDC labeler code 28595
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040396
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 28595-050_5d1e9cac-2c7c-a05e-e063-6394a90a7db2SPL ID 5d1e9cac-2c7c-a05e-e063-6394a90a7db2
- 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
N428595005001followed by a unit qualifier and the quantityPackage 28595-0050-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 28595-050
- What is NDC 28595-050?
- 28595-050 is the product NDC for Hydrocortisone Acetate Cream, Hydrocortisone acetate 20 mg/g cream, listed with the FDA by Allegis Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone Acetate Cream.
- What is the active ingredient?
- Hydrocortisone acetate.
- Who is the labeler?
- Allegis Pharmaceuticals, Inc., NDC labeler code 28595. 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 Acetate Cream?
- 1 other product NDC are listed under this name. See all Hydrocortisone Acetate Cream NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocortisone Acetate Cream 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 Acetate Cream | Hydrocortisone acetate 20 mg/g | CreamTopical | Allegis Holdings LLC | 71297-241 | 71297-0241-01 |
Other NDCs under ANDA 040396
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 Acetate Cream | Hydrocortisone acetate 20 mg/g | CreamTopical | Allegis Holdings LLC | 71297-241 |