NDC codes

FDA NDC Directory
Product NDC (as listed)0178-0500Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00178-0500Add 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
0178-0500-0100178050001100 TABLET in 1 BOTTLE (0178-0500-01)Marketed from May 31, 1983

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Lithostat
Generic name (nonproprietary)
acetohydroxamic acid
Active ingredients
Acetohydroxamic acid — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Mission Pharmacal CompanyNDC labeler code 0178
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 018749
Marketing start
Listing expires
Other FDA classes
Urease Inhibitors (Mechanism)
Identifiers
Product ID 0178-0500_47e7b4dd-b3b1-f6a0-e063-6294a90a1bcaSPL ID 47e7b4dd-b3b1-f6a0-e063-6294a90a1bcaSPL set ID 6660b616-a82d-9109-19ce-2bdf9747aceaRxCUI 197308, 213557UNII 4RZ82L2GY5UPC 0301780500019
Pharmacologic class
Urease Inhibitor

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400178050001 followed by a unit qualifier and the quantity

Package 00178-0500-01. 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 Acetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection. AHA is intended to decrease urinary ammonia and alkalinity, but it should not be used in lieu of curative surgical treatment (for patients with stones) or antimicrobial treatment. Long-term treatment with AHA may be warranted to maintain urease inhibition as long as urea-splitting infection is present. Experience with AHA does not go beyond 7 years. A patient package insert should be distributed to each patient who receives AHA.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0178-0500

What is NDC 0178-0500?
0178-0500 is the product NDC for Lithostat (acetohydroxamic acid), Acetohydroxamic acid 250 mg/1 tablet, listed with the FDA by Mission Pharmacal Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lithostat (Acetohydroxamic acid).
What is the active ingredient?
Acetohydroxamic acid.
Who is the labeler?
Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lithostat?
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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