Home NDC 68788-8294 Chlorthalidone
Product NDC 68788-8294
11-digit product format 687888294
Labeler code 68788
Product ID 68788-8294_fcd89393-6075-4b43-aa32-54f34f74f578
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA214129
Marketing category ANDA
Marketing start 2022-11-29
Substance CHLORTHALIDONE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A214129-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 A214129-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27
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 · 72 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 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214129-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2020-11-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214129-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2020-11-27 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Chlorthalidone
Listing expiration 2027-12-31 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 68788-8294-3 Chlorthalidone 30 in 1 BOTTLE TABLET 30 5 68788-8294-9 Chlorthalidone 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8294 CHLORTHALIDONE TABLET [PREFERRED PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250302_180cc3c7-6ab7-481b-b860-b20d3599e53f.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 68788-8294-3 68788829403 30 TABLET in 1 BOTTLE (68788-8294-3) 30 tablet 2023-04-20 No No Current 68788-8294-9 68788829409 90 TABLET in 1 BOTTLE (68788-8294-9) 90 tablet 2022-11-29 0000-00-00 No No Current