Home NDC 44523-450 Tinidazole
Product NDC 44523-450
11-digit product format 445230450
Labeler code 44523
Product ID 44523-450_44ecbffa-e4aa-9dd3-e063-6394a90a4d48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tinidazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BioComp Pharma, Inc.
Application NDA021618
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-03-20
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 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021618-001 TINDAMAX TINIDAZOLE 250MG TABLET / ORAL AB RLD 2004-05-17 N021618-002 TINDAMAX TINIDAZOLE 500MG TABLET / ORAL AB RLD, RS 2004-05-17
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 · 84 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 2026-08-18 06:07:40 2026-07 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44523-450-12 Tinidazole 12 in 1 BOTTLE TABLET, FILM COATED 12 5 44523-450-20 Tinidazole 20 in 1 BOTTLE TABLET, FILM COATED 20 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tinidazole ACTIVE INGREDIENT 033KF7V46H TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Tinidazole ACTIVE MOIETY 033KF7V46H TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Polydextrose INACTIVE INGREDIENT VH2XOU12IE TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1 Triacetin INACTIVE INGREDIENT XHX3C3X673 TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-450 TINIDAZOLE TABLET, FILM COATED [BIO COMP PHARMA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250327_f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c.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 Marketing start Sample Exclude flag Status 44523-450-12 44523045012 12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12) 2025-03-20 No No Current 44523-450-20 44523045020 20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20) 2025-03-20 No No Current