NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2040Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2040Add 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
63629-2040-16362920400163629204001227 g in 1 BOTTLE (63629-2040-1)Marketed from Sep 19, 2014

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
Generic name (nonproprietary)
urea
Active ingredients
Urea — 40 g/100g
Dosage form
Lotion
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 63629-2040_8346b38d-4599-4fb7-b304-33375e32148dSPL ID 8346b38d-4599-4fb7-b304-33375e32148dSPL set ID 1a6722de-c80a-40b5-b86b-953ef6e5e569RxCUI 351155UNII 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

N463629204001 followed by a unit qualifier and the quantity

Package 63629-2040-01. 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 and Usage For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-2040

What is NDC 63629-2040?
63629-2040 is the product NDC for Urea, Urea 40 g/100g lotion, 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.
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?
8 other product NDCs are listed under this name. See all Urea 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
UreaUrea 400 mg/gLotionTopicalCintex Services, LLC24470-96224470-0962-08
UreaUrea 40 g/100gLotionTopicalAKRON PHARMA INC71399-845571399-8455-08
UreaUrea 200 mg/gCreamTopicalBioComp Pharma, Inc.44523-61844523-0618-03
UreaUrea 400 mg/gCreamTopicalCintex Services, LLC24470-93924470-0939-0124470-0939-0324470-0939-07
UreaUrea 40 g/100gCreamTopicalAvPAK50268-87250268-0872-1950268-0872-2850268-0872-85
UreaUrea 400 mg/gLotionTopicalBantry Pharma, LLC81542-20181542-0201-08
UreaUrea 400 mg/gCreamTopicalBioComp Pharma, Inc.44523-61744523-0617-0144523-0617-0344523-0617-07
UreaUrea 39 g/100gCreamTopicalBryant Ranch Prepack63629-203663629-2036-01

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