Prescription drug · NDA
Aridol Bronchial Challenge Test Kit NDC 67850-552
mannitol · Kit · Methapharm, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67850-552-01 | 67850055201 | 1 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.
- 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
N467850055201followed by a unit qualifier and the quantityPackage 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.