Home NDC 40032-550 Tinidazole
Product NDC 40032-550
11-digit product format 400320550
Labeler code 40032
Product ID 40032-550_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tinidazole
Dosage form TABLET
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA202044
Marketing category ANDA
Marketing start 2012-04-30
Marketing end 0000-00-00
Substance TINIDAZOLE
Active strength 250 mg/1
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A202044-001 TINIDAZOLE 250MG TABLET / ORAL AB 2012-04-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202044-002 TINIDAZOLE 500MG TABLET / ORAL AB 2012-04-30 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 40032-550-08 Tinidazole 8 in 1 BOTTLE TABLET 8 3 40032-550-40 Tinidazole 40 in 1 BOTTLE TABLET 40 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TINIDAZOLE ACTIVE INGREDIENT 033KF7V46H TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 TINIDAZOLE ACTIVE MOIETY 033KF7V46H TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 POLYETHYLENE GLYCOL 3000 INACTIVE INGREDIENT SA1B764746 TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-550 TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.] 3 Legacy NDC, 2 package rows 20120529_4e03b4ac-c88a-4044-9d58-0cfcda3db53c.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 Status 40032-550-08 40032055008 8 in 1 BOTTLE Historical 40032-550-40 40032055040 40 in 1 BOTTLE Historical