NDC codes

FDA NDC Directory
Product NDC (as listed)67850-552Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67850-0552Add 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
67850-552-0167850055201678500552011 KIT in 1 KIT (67850-552-01) * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 CAPSULE * 1 POWDER in 1 KITMarketed from Oct 5, 2010

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)
Aridol Bronchial Challenge Test Kit
Generic name (nonproprietary)
mannitol
Dosage form
Kit
Labeler
Methapharm, Inc.NDC labeler code 67850
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022368
Marketing start
Marketing end
Identifiers
Product ID 67850-552_9817d443-1af2-41a9-80de-a54e3980cd7cSPL ID 9817d443-1af2-41a9-80de-a54e3980cd7cSPL set ID 5387a4fb-b894-4cba-88a3-a947217d34daUPC 0367850552012

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

N467850055201 followed by a unit qualifier and the quantity

Package 67850-0552-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma. ARIDOL is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. ( 1 ) Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be u…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67850-552

What is NDC 67850-552?
67850-552 is the product NDC for Aridol Bronchial Challenge Test Kit kit, listed with the FDA by Methapharm, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aridol Bronchial Challenge Test Kit (Mannitol).
Who is the labeler?
Methapharm, Inc., NDC labeler code 67850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aridol Bronchial Challenge Test Kit?
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.

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