Home NDC 33342-425-07 Chlorthalidone
Product NDC 33342-425
Requested package NDC 33342-425-07
11-digit product format 333420425
Labeler code 33342
Product ID 33342-425_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 25 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 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 33342-425-07 33342042507 30 TABLET in 1 BOTTLE (33342-425-07) 30 tablet 2026-07-01 0 Current