Home NDC 70518-4727 Tinidazole
Product NDC 70518-4727
11-digit product format 705184727
Labeler code 70518
Product ID 70518-4727_5965b16b-36e9-1b69-e063-6294a90a2bf0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tinidazole
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA203808
Marketing category ANDA
Marketing start 2026-08-18
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 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 A203808-001 TINIDAZOLE TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 A203808-002 TINIDAZOLE TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04
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 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203808-001 TINIDAZOLE 250MG TABLET / ORAL AB 2015-08-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203808-002 TINIDAZOLE 500MG TABLET / ORAL AB 2015-08-04 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 Tinidazole
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.
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 Units Marketing start Sample Exclude flag Status 70518-4727-0 70518472700 10 TABLET in 1 BOTTLE, PLASTIC (70518-4727-0) 10 tablet 2026-08-18 No No Current