Home NDC 65162-247 Chlorthalidone
Product NDC 65162-247
11-digit product format 651620247
Labeler code 65162
Product ID 65162-247_6489aee4-4593-4cc5-97dc-24a7a2eaab67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA207204
Marketing category ANDA
Marketing start 2019-07-01
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 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 A207204-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 A207204-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01
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 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207204-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2019-07-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207204-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2019-07-01 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197499 Internal RxNorm lookup 197500 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 65162-247-03 Chlorthalidone 30 in 1 BOTTLE TABLET 30 12 65162-247-09 Chlorthalidone 90 in 1 BOTTLE TABLET 90 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-247 CHLORTHALIDONE TABLET [AMNEAL PHARMACEUTICALS LLC] 12 Current NDC, Legacy NDC, 2 package rows 20241210_c4c1bfe5-b5c8-43c0-9428-62337095b2bd.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 65162-247-03 65162024703 30 TABLET in 1 BOTTLE (65162-247-03) 30 tablet 2019-07-01 0000-00-00 No No Current 65162-247-09 65162024709 90 TABLET in 1 BOTTLE (65162-247-09) 90 tablet 2019-07-01 0000-00-00 No No Current