Home NDC 33342-426-07 Chlorthalidone
Product NDC 33342-426
Requested package NDC 33342-426-07
11-digit product format 333420426
Labeler code 33342
Product ID 33342-426_5de362df-8fb9-4421-864c-7ea06339d6e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA212229
Marketing category ANDA
Marketing start 2026-07-01
Substance CHLORTHALIDONE
Active strength 50 mg/1
Pharmacologic classes Increased Diuresis [PE]; Thiazide-like Diuretic [EPC]
Listing certified through 2027-12-31
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 A212229-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2026-07-01 A212229-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2026-07-01
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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212229-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212229-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2026-07-01 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212229-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212229-002 AB 1 a50c72e98297…
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
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 33342-426-07 33342042607 30 TABLET in 1 BOTTLE (33342-426-07) 30 tablet 2026-07-01 0 Current