NDC codes

FDA NDC Directory
Product NDC (as listed)63629-9267Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-9267Add 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
63629-9267-16362992670163629926701198.4 g in 1 BOTTLE (63629-9267-1)Marketed from Apr 4, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Urea 40 Percent
Generic name (nonproprietary)
urea
Active ingredients
Urea — 400 mg/g
Dosage form
Cream
Route
Topical
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 63629-9267_e91f44df-bbf1-484a-b84f-73ca9e47545eSPL ID e91f44df-bbf1-484a-b84f-73ca9e47545eSPL set ID 6701225c-2c2e-41e8-8d43-ef77c00a9946RxCUI 198342UNII 8W8T17847W

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

N463629926701 followed by a unit qualifier and the quantity

Package 63629-9267-01. 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: This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-9267

What is NDC 63629-9267?
63629-9267 is the product NDC for Urea 40 Percent (urea), Urea 400 mg/g cream, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Urea 40 Percent (Urea).
What is the active ingredient?
Urea.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Urea 40 Percent?
3 other product NDCs are listed under this name. See all Urea 40 Percent 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 Urea 40 Percent NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Urea 40 PercentureaUrea 400 mg/gCreamTopicalMethod Pharmaceuticals, LLC58657-48758657-0487-0158657-0487-0358657-0487-07
Urea 40 PercentureaUrea 400 mg/gCreamTopicalBryant Ranch Prepack71335-289071335-2890-01
Urea 40 PercentureaUrea 400 mg/gCreamTopicalBryant Ranch Prepack72162-166872162-1668-02

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