Home NDC 70518-4172 Tindazole
Product NDC 70518-4172
11-digit product format 705184172
Labeler code 70518
Product ID 70518-4172_59513899-6da6-e4bf-e063-6294a90afcf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tinidazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA202489
Marketing category ANDA
Marketing start 2024-08-30
Substance TINIDAZOLE
Active strength 500 mg/1
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
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 · 3 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 70518-4172 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-4172 70518-4172-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-4172 70518-4172-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202489-001 TINIDAZOLE TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 A202489-002 TINIDAZOLE TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 Tindazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TINIDAZOLE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 033KF7V46H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199519 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4172 TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [REMEDYREPACK INC.] 1 Current NDC 20240906_45fa3ebd-52da-4987-82a1-4a64f99785a7.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-4172-0 70518417200 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) 2024-08-30 No No Current