Home NDC 31722-756 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product NDC 31722-756
11-digit product format 317220756
Labeler code 31722
Product ID 31722-756_53cf5c1a-4169-a808-e063-6294a90acc4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA219869
Marketing category ANDA
Marketing start 2026-05-27
Substance LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength 100; 12.5 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219869-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET / ORAL AB 2026-05-27 A219869-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET / ORAL AB 2026-05-27 A219869-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET / ORAL AB 2026-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A219869-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2026-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219869-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2026-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219869-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2026-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219869-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2026-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219869-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2026-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219869-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2026-05-27 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219869-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2026-05-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219869-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2026-05-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219869-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2026-05-27 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 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOSARTAN POTASSIUM 100 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup 3ST302B24A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979464 Internal RxNorm lookup 979468 Internal RxNorm lookup 979471 Internal RxNorm 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 Marketing start Sample Exclude flag Status 31722-756-10 31722075610 1000 TABLET, FILM COATED in 1 BOTTLE (31722-756-10) 2026-05-27 No No Current 31722-756-30 31722075630 30 TABLET, FILM COATED in 1 BOTTLE (31722-756-30) 2026-05-27 No No Current 31722-756-90 31722075690 90 TABLET, FILM COATED in 1 BOTTLE (31722-756-90) 2026-05-27 No No Current