What is NDC 67334-0457?

67334-0457 is the product NDC for T.R.U.E. Test Thin-Layer Rapid Use Patch Test kit, listed with the FDA by SmartPractice Denmark ApS. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

T.R.U.E. Test Thin-Layer Rapid Use Patch Test (Standardized Allergenic).

SmartPractice Denmark ApS, NDC labeler code 67334. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for T.R.U.E. Test Thin-Layer Rapid Use Patch Test?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 67334-0457

NDC codes

FDA NDC Directory

Product NDC (as listed)67334-0457Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67334-0457Add 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 NDC	11-digit (billing)	Package	Copy
67334-0457-5	67334045705	5 BAG in 1 BOX (67334-0457-5) / 1 KIT in 1 BAG (67334-0457-1) * 1 PATCH in 1 POUCH / 48 h in 1 PATCH * 1 PATCH in 1 POUCH / 48 h in 1 PATCH * 1 PATCH in 1 POUCH / 48 h in 1 PATCHMarketed from Mar 1, 2012

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): T.R.U.E. Test Thin-Layer Rapid Use Patch TestSuffix: Thin-Layer Rapid Use Patch Test
Generic name (nonproprietary): standardized allergenic
Dosage form: Kit
Route: Cutaneous
Labeler: SmartPractice Denmark ApSNDC labeler code 67334
Product type: Standardized allergenic
Marketing category: BLA — Biologics License ApplicationApplication BLA 103738
Marketing start: Mar 1, 2012
Listing expires: Dec 31, 2026
Identifiers: Product ID 67334-0457_26f6e77a-2e23-2f94-e063-6394a90a19c1SPL ID 26f6e77a-2e23-2f94-e063-6394a90a19c1

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N467334045705 followed by a unit qualifier and the quantity

Package 67334-0457-05. 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 67334-0457

What is NDC 67334-0457?: 67334-0457 is the product NDC for T.R.U.E. Test Thin-Layer Rapid Use Patch Test kit, listed with the FDA by SmartPractice Denmark ApS. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: T.R.U.E. Test Thin-Layer Rapid Use Patch Test (Standardized Allergenic).
Who is the labeler?: SmartPractice Denmark ApS, NDC labeler code 67334. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for T.R.U.E. Test Thin-Layer Rapid Use Patch Test?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

T.R.U.E. Test Thin-Layer Rapid Use Patch Test (Standardized allergenic) NDC 67334-0457