Home NDC 0178-0500 Lithostat
Product NDC 0178-0500
11-digit product format 001780500
Labeler code 0178
Product ID 0178-0500_47e7b4dd-b3b1-f6a0-e063-6294a90a1bca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetohydroxamic acid
Dosage form TABLET
Route ORAL
Labeler Mission Pharmacal Company
Application NDA018749
Marketing category NDA
Marketing start 1983-05-31
Substance ACETOHYDROXAMIC ACID
Active strength 250 mg/1
Pharmacologic classes Urease Inhibitor [EPC], Urease Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018749-001 LITHOSTAT ACETOHYDROXAMIC ACID 250MG TABLET / ORAL RLD, RS 1983-05-31
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Lithostat
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETOHYDROXAMIC ACID 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4RZ82L2GY5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197308 Internal RxNorm lookup 213557 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0178-0500-01 Lithostat 100 in 1 BOTTLE TABLET 100 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0178-0500 LITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY] 6 Current NDC, Legacy NDC, 1 package rows 20240110_6660b616-a82d-9109-19ce-2bdf9747acea.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0178-0500-01 00178050001 100 TABLET in 1 BOTTLE (0178-0500-01) 100 tablet 1983-05-31 0000-00-00 No No Current