Home NDC 72603-721 Candesartan
Product NDC 72603-721
11-digit product format 726030721
Labeler code 72603
Product ID 72603-721_400810c5-9f59-4285-a3f6-fa98bba0c6a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan
Dosage form TABLET
Route ORAL
Labeler NorthStar RxLLC
Application ANDA203813
Marketing category ANDA
Marketing start 2025-01-29
Substance CANDESARTAN CILEXETIL
Active strength 32 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203813-001 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 A203813-002 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 A203813-003 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 A203813-004 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203813-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2016-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203813-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2016-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203813-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2016-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203813-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2016-12-05 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Candesartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANDESARTAN CILEXETIL 32 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R85M2X0D68 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577776 Internal RxNorm lookup 639537 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 72603-721-01 Candesartan 90 in 1 CARTON TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-721 CANDESARTAN TABLET [NORTHSTAR RXLLC] 1 Current NDC, 1 package rows 20250130_880f685f-be01-42f4-9e76-ebd1fcfb1f77.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72603-721-01 72603072101 90 TABLET in 1 CARTON (72603-721-01) 90 tablet 2025-01-29 No No Current