Home NDC 33342-116 Candesartan
Product NDC 33342-116
11-digit product format 333420116
Labeler code 33342
Product ID 33342-116_4079c843-42ee-4f7a-a4a0-9498ba6cf12d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203813
Marketing category ANDA
Marketing start 2016-12-06
Substance CANDESARTAN CILEXETIL
Active strength 16 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 16 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153822 Internal RxNorm lookup 153823 Internal RxNorm lookup 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 33342-116-07 Candesartan 30 in 1 CONTAINER TABLET 30 6 33342-116-10 Candesartan 90 in 1 CONTAINER TABLET 90 6 33342-116-12 Candesartan 10 in 1 BLISTER PACK TABLET 10 6 33342-116-12 Candesartan 10 in 1 CARTON TABLET 10 6 33342-116-51 Candesartan 300 in 1 CONTAINER TABLET 300 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-116 CANDESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED] 6 Current NDC, Legacy NDC, 5 package rows 20221231_8ceb5658-b03c-475d-9ef0-2cd0645191d3.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 Marketing end Sample Exclude flag Status 33342-116-07 33342011607 30 TABLET in 1 CONTAINER (33342-116-07) 30 tablet 2016-12-06 0000-00-00 No No Current 33342-116-10 33342011610 90 TABLET in 1 CONTAINER (33342-116-10) 90 tablet 2016-12-06 0000-00-00 No No Current 33342-116-12 33342011612 10 BLISTER PACK in 1 CARTON (33342-116-12) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2016-12-06 0000-00-00 No No Current 33342-116-51 33342011651 300 TABLET in 1 CONTAINER (33342-116-51) 300 tablet 2016-12-06 0000-00-00 No No Current