Home NDC 0378-3231 candesartan cilexetil
Product NDC 0378-3231
11-digit product format 003783231
Labeler code 0378
Product ID 0378-3231_62815e9d-598e-4b5f-b33b-3a9659eec024
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name candesartan cilexetil
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA078702
Marketing category ANDA
Marketing start 2020-01-06
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 A078702-001 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 A078702-002 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 A078702-003 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 A078702-004 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03
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 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078702-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2013-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078702-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2013-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078702-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2013-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078702-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2013-05-03 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 cilexetil
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 0378-3231-77 candesartan cilexetil 90 in 1 BOTTLE, PLASTIC TABLET 90 4 0378-3231-93 candesartan cilexetil 30 in 1 BOTTLE, PLASTIC TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-3231 CANDESARTAN CILEXETIL TABLET [MYLAN PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240126_904b357e-97bf-475e-90a5-f0449f2a428e.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 · 1 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 0378-3231-77 00378323177 90 TABLET in 1 BOTTLE, PLASTIC (0378-3231-77) 90 tablet 2020-01-06 0000-00-00 No No Current 0378-3231-93 00378323193 30 TABLET in 1 BOTTLE, PLASTIC (0378-3231-93) 30 tablet 2020-01-06 0000-00-00 No No Current