NDC codes

FDA NDC Directory
Product NDC (as listed)21922-007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0007Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
21922-007-0421922000704219220007041 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBEMarketed from Dec 31, 2022
21922-007-0621922000706219220007061 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBEMarketed from Dec 31, 2022
21922-007-0721922000707219220007071 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

N421922000704 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other hydrocortisone valerate cream NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
hydrocortisone valerate creamHydrocortisone valerate 2 mg/gCreamTopicalBryant Ranch Prepack71335-272371335-2723-01
hydrocortisone valerate creamHydrocortisone valerate 2 mg/gCreamTopicalBryant Ranch Prepack71335-284371335-2843-01
hydrocortisone valerate creamHydrocortisone valerate 2 mg/gCreamTopicalBryant Ranch Prepack72162-230172162-2301-0472162-2301-06

Other NDCs under ANDA 211047

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211047
ProductStrengthForm · routeLabelerProduct NDC
hydrocortisone valerate creamHydrocortisone valerate 2 mg/gCreamTopicalBryant Ranch Prepack71335-2723
hydrocortisone valerate creamHydrocortisone valerate 2 mg/gCreamTopicalBryant Ranch Prepack71335-2843
hydrocortisone valerate creamHydrocortisone valerate 2 mg/gCreamTopicalBryant Ranch Prepack72162-2301

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