Home NDC 83980-062 Chlorthalidone
Product NDC 83980-062
11-digit product format 839800062
Labeler code 83980
Product ID 83980-062_b1a9b0ed-396f-41cc-b975-349b61b99d14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Ipca Laboratories Limited
Application ANDA209162
Marketing category ANDA
Marketing start 2026-09-21
Substance CHLORTHALIDONE
Active strength 50 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A209162-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 A209162-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12
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.
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 2026-09-14 22:38:34 2026-08 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209162-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209162-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2024-11-12 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Chlorthalidone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORTHALIDONE 50 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83980-062-01 83980006201 100 TABLET in 1 BOTTLE (83980-062-01) 100 tablet 2026-09-21 No No Current 83980-062-10 83980006210 1000 TABLET in 1 BOTTLE (83980-062-10) 1000 tablet 2026-09-21 No No Current 83980-062-13 83980006213 30 TABLET in 1 BOTTLE (83980-062-13) 30 tablet 2026-09-21 No No Current 83980-062-19 83980006219 90 TABLET in 1 BOTTLE (83980-062-19) 90 tablet 2026-09-21 No No Current