Home NDC 43386-550 Tinidazole
Product NDC 43386-550
11-digit product format 433860550
Labeler code 43386
Product ID 43386-550_98a66e10-fb32-46ce-a68b-c21d615f6621
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tinidazole
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA202044
Marketing category ANDA
Marketing start 2012-04-30
Substance TINIDAZOLE
Active strength 250 mg/1
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A202044-001 TINIDAZOLE TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 A202044-002 TINIDAZOLE TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30
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 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tinidazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TINIDAZOLE 250 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199519 Internal RxNorm lookup 477234 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43386-550-04 Tinidazole 40 in 1 BOTTLE TABLET 40 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TINIDAZOLE ACTIVE INGREDIENT 033KF7V46H TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 TINIDAZOLE ACTIVE MOIETY 033KF7V46H TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 POLYETHYLENE GLYCOL 3000 INACTIVE INGREDIENT SA1B764746 TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-550 TINIDAZOLE TABLET [LUPIN PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 1 package rows 20230623_95ab57b2-5d7e-4986-abcd-65edf1728383.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.
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 43386-550-04 43386055004 40 TABLET in 1 BOTTLE (43386-550-04) 40 tablet 2012-04-30 0000-00-00 No No Current