Prescription drug · NDA
Lithostat (Acetohydroxamic acid) NDC 0178-0500
Acetohydroxamic acid 250 mg/1 · Tablet · Oral · Mission Pharmacal Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0178-0500-01 | 00178050001 | 100 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
N400178050001followed by a unit qualifier and the quantityPackage 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.
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.