Home NDC 68071-5219 Chlorthalidone
Product NDC 68071-5219
11-digit product format 680715219
Labeler code 68071
Product ID 68071-5219_d7730674-750e-52cf-e053-2995a90ab32c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA211063
Marketing category ANDA
Marketing start 2019-06-24
Marketing end 0000-00-00
Substance CHLORTHALIDONE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-5219-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-5219-3 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-5219-3 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-5219-3 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-5219-3 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-5219-3 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-5219-3 302b2466d912…e7b80fea0513…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 68071-5219-3 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 68071-5219-3 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68071-5219-3 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-5219-3 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-5219-3 557ba5c1ecfa…9c80585c8c6e…
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.
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-5219-3 68071521903 30 TABLET in 1 BOTTLE (68071-5219-3) 30 tablet 2020-03-18 0000-00-00 No No Current