Home NDC 0178-8500 Tindamax
Product NDC 0178-8500
11-digit product format 001788500
Labeler code 0178
Product ID 0178-8500_d423971d-34c8-c7d2-e053-2a95a90abe74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tinidazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mission Pharmacal Company
Application NDA021618
Marketing category NDA
Marketing start 2004-05-17
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 Tindamax
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199519 Internal RxNorm lookup 477234 Internal RxNorm lookup 539809 Internal RxNorm lookup 539811 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 0178-8500-04 Tindamax 4 in 1 BOTTLE TABLET, FILM COATED 4 9 0178-8500-20 Tindamax 20 in 1 BOTTLE TABLET, FILM COATED 20 9 0178-8500-60 Tindamax 60 in 1 BOTTLE TABLET, FILM COATED 60 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tinidazole ACTIVE INGREDIENT 033KF7V46H TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 Tinidazole ACTIVE MOIETY 033KF7V46H TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 3 TINIDAZOLE ACTIVE INGREDIENT 033KF7V46H TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TINIDAZOLE ACTIVE MOIETY 033KF7V46H TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0178-8500 TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] 9 Current NDC, Legacy NDC, 3 package rows 20211228_a0d01539-8413-4703-94cc-d221918630a1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0178-8500-04 00178850004 4 in 1 BOTTLE Historical 0178-8500-20 00178850020 20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20) 2004-05-17 0000-00-00 No No Current 0178-8500-60 00178850060 60 TABLET, FILM COATED in 1 BOTTLE (0178-8500-60) 2004-05-17 0000-00-00 No No Current