Home NDC 72189-356 Chlorthalidone
Product NDC 72189-356
11-digit product format 721890356
Labeler code 72189
Product ID 72189-356_2c4c9187-3303-d75f-e063-6394a90a9231
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Direct_Rx
Application ANDA211627
Marketing category ANDA
Marketing start 2022-05-10
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-356-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-356-60 0efc9e666f02…f202fb6c5f17…
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 A211627-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 A211627-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06
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 2 · 80 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 2026-02-19 14:30 UTC 2026-02 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211627-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-08-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211627-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-08-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 72189-356-60 Chlorthalidone 60 in 1 BOTTLE TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-356 CHLORTHALIDONE TABLET [DIRECT_RX] 2 Current NDC, Legacy NDC, 1 package rows 20250123_deab1d3e-759f-480e-e053-2995a90a0a75.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72189-356-60 72189035660 60 TABLET in 1 BOTTLE (72189-356-60) 60 tablet 2022-05-10 0000-00-00 No No Current