Home NDC 53002-1623 CHLORTHALIDONE
Product NDC 53002-1623
11-digit product format 530021623
Labeler code 53002
Product ID 53002-1623_449028a8-d660-4e80-8498-c0778f87d513
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORTHALIDONE
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA206904
Marketing category ANDA
Marketing start 2017-05-17
Marketing end 0000-00-00
Substance CHLORTHALIDONE
Active strength 25 mg/1
Pharmacologic classes Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 33 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-1623-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-1623-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-1623-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-1623-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-1623-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-1623-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-1623-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-1623-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-1623-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-1623-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-1623-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-1623-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-1623-0 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-1623-3 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-1623-0 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-1623-3 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-1623-0 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-1623-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53002-1623-0 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53002-1623-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-1623-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-1623-0 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 A206904-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 A206904-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30
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 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-1623-0 2025-01-30 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-3 2025-01-30 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-0 2023-06-07 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-3 2023-06-07 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-0 2023-01-30 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-3 2023-01-30 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-0 2020-12-15 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-3 2020-12-15 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-0 2020-01-31 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg 53002-1623-3 2020-01-31 CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-1623-0 CHLORTHALIDONE 100 in 1 BOTTLE TABLET 100 5 53002-1623-3 CHLORTHALIDONE 30 in 1 BOTTLE TABLET 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-1623 CHLORTHALIDONE TABLET [RPK PHARMACEUTICALS, INC.] 5 Legacy NDC, 2 package rows 20230609_9b5c2ff4-d427-4f37-826a-7bac6abad735.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 · 2 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 53002-1623-0 53002162300 100 TABLET in 1 BOTTLE (53002-1623-0) 100 tablet 2017-09-01 0000-00-00 No No Current 53002-1623-3 53002162303 30 TABLET in 1 BOTTLE (53002-1623-3) 30 tablet 2017-09-01 0000-00-00 No No Current