Home NDC 71335-2935 Chlorthalidone
Product NDC 71335-2935
11-digit product format 713352935
Labeler code 71335
Product ID 71335-2935_bfae447d-61c7-47f6-b7d9-e972c7a7963c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA212878
Marketing category ANDA
Marketing start 2022-08-05
Substance CHLORTHALIDONE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212878-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212878-001 AB
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 2026-09-14 22:38:34 2026-08 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212878-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-02-24 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Chlorthalidone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORTHALIDONE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q0MQD1073Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197499 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 71335-2935-1 Chlorthalidone 1000 in 1 BOTTLE TABLET 1000 100
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2935-1 71335293501 1000 TABLET in 1 BOTTLE (71335-2935-1) 1000 tablet 2025-10-28 No No Current