Prescription drug · ANDA
hydrocortisone valerate cream NDC 21922-007
Hydrocortisone valerate 2 mg/g · Cream · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-007-04 | 2192200070421922000704 | 1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBEMarketed from Dec 31, 2022 | |
| 21922-007-06 | 2192200070621922000706 | 1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBEMarketed from Dec 31, 2022 | |
| 21922-007-07 | 2192200070721922000707 | 1 TUBE in 1 CARTON (21922-007-07) / 60 g in 1 TUBEMarketed from Dec 31, 2022 |
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 valerate cream
- Generic name (nonproprietary)
- hydrocortisone valerate cream
- Active ingredients
- Hydrocortisone valerate — 2 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211047
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 21922-007_85b1a924-1037-419a-a141-878a1539f013SPL ID 85b1a924-1037-419a-a141-878a1539f013SPL set ID 41723504-b2cf-4074-9c3a-e3c59bb48c98RxCUI 1370754UNII 68717P8FUZUPC 0321922007060, 0321922007046
- 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
N421922000704followed by a unit qualifier and the quantityPackage 21922-0007-04. 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 Hydrocortisone valerate cream USP, 0.2% is medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
Excerpt only. Read the full label for complete information.
About NDC 21922-007
- What is NDC 21922-007?
- 21922-007 is the product NDC for hydrocortisone valerate cream, Hydrocortisone valerate 2 mg/g cream, listed with the FDA by Encube Ethicals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- hydrocortisone valerate cream.
- What is the active ingredient?
- Hydrocortisone valerate.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 valerate cream?
- 3 other product NDCs are listed under this name. See all hydrocortisone valerate 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 valerate 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 valerate cream | Hydrocortisone valerate 2 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2723 | 71335-2723-01 |
| hydrocortisone valerate cream | Hydrocortisone valerate 2 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2843 | 71335-2843-01 |
| hydrocortisone valerate cream | Hydrocortisone valerate 2 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2301 | 72162-2301-0472162-2301-06 |
Other NDCs under ANDA 211047
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 valerate cream | Hydrocortisone valerate 2 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2723 |
| hydrocortisone valerate cream | Hydrocortisone valerate 2 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2843 |
| hydrocortisone valerate cream | Hydrocortisone valerate 2 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2301 |