Home NDC 42799-208 Tinidazole
Product NDC 42799-208
11-digit product format 427990208
Labeler code 42799
Product ID 42799-208_462f7240-9709-4782-e063-6294a90a9e28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tinidazole
Dosage form TABLET
Route ORAL
Labeler Edenbridge Pharmaceuticals LLC.
Application ANDA203808
Marketing category ANDA
Marketing start 2019-12-20
Substance TINIDAZOLE
Active strength 500 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Tinidazole
Listing expiration 2026-12-31 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 · 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 42799-208-01 Tinidazole 20 in 1 BOTTLE TABLET 20 9 42799-208-02 Tinidazole 60 in 1 BOTTLE TABLET 60 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tinidazole ACTIVE INGREDIENT 033KF7V46H TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 Tinidazole ACTIVE MOIETY 033KF7V46H TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42799-208 TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] 7 Current NDC, Legacy NDC, 2 package rows 20250406_6f3ce597-64c1-4204-a67a-8b6f6e7e8bca.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 42799-208-01 42799020801 20 TABLET in 1 BOTTLE (42799-208-01) 20 tablet 2019-12-20 0000-00-00 No No Current 42799-208-02 42799020802 60 TABLET in 1 BOTTLE (42799-208-02) 60 tablet 2019-12-20 0000-00-00 No No Current