Tribenzor

Product NDC: 0713-0874
Requested package NDC: 0713-0874-30
11-digit product format: 007130874
Labeler code: 0713
Product ID: 0713-0874_004953ba-fe11-03eb-e063-6394a90a638c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cosette Pharmaceuticals, Inc.
Application: NDA200175
Marketing category: NDA
Marketing start: 2022-09-01
Substance: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength: 5; 12.5; 20 mg/1; mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200175-001	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-002	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-003	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-004	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-005	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N200175-001	AB
N200175-002	AB
N200175-003	AB
N200175-004	AB
N200175-005	AB

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 6 · 205 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	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200175-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200175-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200175-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200175-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tribenzor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLMESARTAN MEDOXOMIL	5 mg/1
AMLODIPINE BESYLATE	12.5 mg/1
HYDROCHLOROTHIAZIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J48LPH2TH	Internal UNII lookup
6M97XTV3HD	Internal UNII lookup
864V2Q084H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
999967	Internal RxNorm lookup
999971	Internal RxNorm lookup
999986	Internal RxNorm lookup
999990	Internal RxNorm lookup
999991	Internal RxNorm lookup
999995	Internal RxNorm lookup
999996	Internal RxNorm lookup
1000000	Internal RxNorm lookup
1000001	Internal RxNorm lookup
1000005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2f56d0bc-236b-41a0-9fc0-21cdfea8d890	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
caadbc51-b731-1a7b-b91a-f7bb4a62554e	Product name	9	20240306
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0713-0874-30	Tribenzor	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0874-30	EA - Each	0713-0874	dfeac6ed-eb42-45da-8e9f-a2bcb06e4c65	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0713-0874	TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20230713_2f56d0bc-236b-41a0-9fc0-21cdfea8d890.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tribenzor	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Cosette Pharmaceuticals, Inc.	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200175 application number: NDA200175 ndc (package): 0713-0874-30 ndc (product): 0713-0874 ndc11 (package): 00713087430

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
999967	olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999986	olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999991	olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999996	olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000001	olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999971	TRIBENZOR 20 MG / 5 MG / 12.5 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999990	TRIBENZOR 40 MG / 10 MG / 12.5 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999995	TRIBENZOR 40 MG / 10 MG / 25 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000000	TRIBENZOR 40 MG / 5 MG / 12.5 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000005	TRIBENZOR 40 MG / 5 MG / 25 MG Oral Tablet	PSN	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999990	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SBD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999995	amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SBD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999971	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]	SBD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000000	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SBD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000005	amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SBD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999986	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999991	amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999967	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SCD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999996	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000001	amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999991	amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000001	amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999996	amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999986	amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999967	amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999986	Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999990	Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999991	Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999995	Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999967	Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999971	Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999996	Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000000	Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000001	Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000005	Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999971	Tribenzor 20/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999990	Tribenzor 40/10/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
999995	Tribenzor 40/10/25 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000000	Tribenzor 40/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3
1000005	Tribenzor 40/5/25 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral Tablet	SY	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0713-0874-30	00713087430	30 TABLET, FILM COATED in 1 BOTTLE (0713-0874-30)	2022-09-01	0000-00-00	No	No	Current