Home NDC 46708-677 CHLORTHALIDONE
Product NDC 46708-677
11-digit product format 467080677
Labeler code 46708
Product ID 46708-677_1b98d1a1-9d3d-41d2-a5e9-744b851d30d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORTHALIDONE
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA216262
Marketing category ANDA
Marketing start 2022-08-29
Substance CHLORTHALIDONE
Active strength 50 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 A216262-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 A216262-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26
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 2 · 54 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 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216262-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2022-08-26 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216262-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2022-08-26 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CHLORTHALIDONE
Brand name suffix CHLORTHALIDONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORTHALIDONE 50 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 46708-677-31 CHLORTHALIDONECHLORTHALIDONE 100 in 1 BOTTLE TABLET 100 1 46708-677-90 CHLORTHALIDONECHLORTHALIDONE 90 in 1 BOTTLE TABLET 90 1 46708-677-91 CHLORTHALIDONECHLORTHALIDONE 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-677 CHLORTHALIDONE CHLORTHALIDONE (CHLORTHALIDONE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, Legacy NDC, 3 package rows 20221007_1b98d1a1-9d3d-41d2-a5e9-744b851d30d4.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 46708-677-31 46708067731 100 TABLET in 1 BOTTLE (46708-677-31) 100 tablet 2022-08-29 0000-00-00 No No Current 46708-677-90 46708067790 90 TABLET in 1 BOTTLE (46708-677-90) 90 tablet 2022-08-29 0000-00-00 No No Current 46708-677-91 46708067791 1000 TABLET in 1 BOTTLE (46708-677-91) 1000 tablet 2022-08-29 0000-00-00 No No Current