Home NDC 0186-0162 ATACAND HCT
Product NDC 0186-0162
11-digit product format 001860162
Labeler code 0186
Product ID 0186-0162_9e314974-b835-461b-b4f4-9f3660ea83ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan cilexetil and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA021093
Marketing category NDA
Marketing start 2000-09-28
Marketing end 2019-07-31
Substance CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength 16 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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021093-001 ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 N021093-002 ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 N021093-003 ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16
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.
Product history page 1 of 4 · 123 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 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CANDESARTAN CILEXETIL ACTIVE INGREDIENT R85M2X0D68 ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 CANDESARTAN ACTIVE MOIETY S8Q36MD2XX ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 CARBOXYMETHYLCELLULOSE CALCIUM INACTIVE INGREDIENT UTY7PDF93L ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET ATACAND HCT (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) TABLET [ASTRAZENECA LP] 18 CANDESARTAN CILEXETIL ACTIVE INGREDIENT R85M2X0D68 ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CANDESARTAN ACTIVE MOIETY S8Q36MD2XX ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CARBOXYMETHYLCELLULOSE CALCIUM INACTIVE INGREDIENT UTY7PDF93L ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2
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 · 2 matching rows.
DailyMed RxNorm Mappings#