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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 0178-0500 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0178-0500 0178-0500-01 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018749-001 LITHOSTAT 250MG TABLET / ORAL RLD, RS 1983-05-31 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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