Home NDC 44523-450-12 Tinidazole
Product NDC 44523-450
Requested package NDC 44523-450-12
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 2026-08-01 22:54:32 2026-06 N021618-001 TINDAMAX 250MG TABLET / ORAL AB RLD 2004-05-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N021618-002 TINDAMAX 500MG TABLET / ORAL AB RLD, RS 2004-05-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021618-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N021618-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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
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