Home NDC 14803-505 Chlorthalidone
Product NDC 14803-505
11-digit product format 148030505
Labeler code 14803
Product ID 14803-505_8877d35e-6211-74d8-e053-2995a90a29e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Elysium Pharmaceuticals Limited
Application ANDA211063
Marketing category ANDA
Marketing start 2019-05-09
Marketing end 0000-00-00
Substance CHLORTHALIDONE
Active strength 25 1/1
Pharmacologic classes Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A211063-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 A211063-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26
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 · 82 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 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211063-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-02-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211063-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-02-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 · 1 matching rows.