Home NDC 64980-426 Tindazole
Product NDC 64980-426
11-digit product format 649800426
Labeler code 64980
Product ID 64980-426_8dbd79dd-9243-4413-aa01-ba1301573a48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tinidazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA202489
Marketing category ANDA
Marketing start 2013-10-09
Substance TINIDAZOLE
Active strength 250 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 A202489-001 TINIDAZOLE TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 A202489-002 TINIDAZOLE TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09
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 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202489-001 TINIDAZOLE 250MG TABLET / ORAL AB 2013-10-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202489-002 TINIDAZOLE 500MG TABLET / ORAL AB 2013-10-09 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 Tindazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TINIDAZOLE 250 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 64980-426-02 Tindazole 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-426 TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20230707_32167dd7-5d37-457b-9b00-cd735de6b060.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 Marketing end Sample Exclude flag Status 64980-426-02 64980042602 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02) 2013-10-09 0000-00-00 No No Current