Irbesartan and Hydrochlorothiazide

Product NDC: 33342-058
11-digit product format: 333420058
Labeler code: 33342
Product ID: 33342-058_f2ef667a-4871-4f28-a0b3-3f79fbbe180c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA202414
Marketing category: ANDA
Marketing start: 2012-09-27
Substance: HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength: 12.5; 300 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET / ORAL	AB		2012-09-27
A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET / ORAL	AB		2012-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202414-001	AB
A202414-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202414-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202414-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202414-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202414-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202414-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202414-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202414-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202414-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202414-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202414-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202414-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202414-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202414-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202414-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202414-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202414-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202414-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202414-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Irbesartan and Hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IRBESARTAN	12.5 mg/1
HYDROCHLOROTHIAZIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J48LPH2TH	Internal UNII lookup
J0E2756Z7N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310792	Internal RxNorm lookup
310793	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
1898f438-4571-4aab-ae06-9bf1aabf0486	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
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
34942a29-de4f-d63c-7755-ba18fe1411a0	Product name	6	20180619
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
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
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
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	SPL version
33342-058-06	Irbesartan and Hydrochlorothiazide	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	15
33342-058-06	Irbesartan and Hydrochlorothiazide	3 in 1 CARTON	TABLET, FILM COATED	3	15
33342-058-07	Irbesartan and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET, FILM COATED	30	15
33342-058-10	Irbesartan and Hydrochlorothiazide	90 in 1 BOTTLE	TABLET, FILM COATED	90	15
33342-058-15	Irbesartan and Hydrochlorothiazide	500 in 1 BOTTLE	TABLET, FILM COATED	500	15
33342-058-39	Irbesartan and Hydrochlorothiazide	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	15
33342-058-39	Irbesartan and Hydrochlorothiazide	9 in 1 CARTON	TABLET, FILM COATED	9	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-058-07	EA - Each	33342-058	2a2851ed-0ce9-47ef-becd-4a284e11da7c	1	2013-02-13
33342-058-10	EA - Each	33342-058	7f1176a9-8ed9-4e42-b6a8-9f805bc78204	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-058	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	14	Current NDC, Legacy NDC, 7 package rows	20220723_1898f438-4571-4aab-ae06-9bf1aabf0486.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	46d77ed8-ece2-4f51-b1a4-4a440e2dce2d	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202414 application number: ANDA202414
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Macleods Pharmaceuticals Limited	1898f438-4571-4aab-ae06-9bf1aabf0486	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202414 application number: ANDA202414 ndc (product): 33342-058
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	97b09783-7bba-4f7a-b1b3-86ccf12c7ecc	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202414 application number: ANDA202414

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
J0E2756Z7N	IRBESARTAN	138402-11-6	IRBESARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310792	irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	1898f438-4571-4aab-ae06-9bf1aabf0486	15
310793	irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	1898f438-4571-4aab-ae06-9bf1aabf0486	15
310792	hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet	SCD	1898f438-4571-4aab-ae06-9bf1aabf0486	15
310793	hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral Tablet	SCD	1898f438-4571-4aab-ae06-9bf1aabf0486	15
310792	HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet	SY	1898f438-4571-4aab-ae06-9bf1aabf0486	15
310793	HCTZ 12.5 MG / irbesartan 300 MG Oral Tablet	SY	1898f438-4571-4aab-ae06-9bf1aabf0486	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-058-06	33342005806	3 BLISTER PACK in 1 CARTON (33342-058-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2012-09-27	0000-00-00	No	No	Current
33342-058-07	33342005807	30 TABLET, FILM COATED in 1 BOTTLE (33342-058-07)		2012-09-27	0000-00-00	No	No	Current
33342-058-10	33342005810	90 TABLET, FILM COATED in 1 BOTTLE (33342-058-10)		2012-09-27	0000-00-00	No	No	Current
33342-058-15	33342005815	500 TABLET, FILM COATED in 1 BOTTLE (33342-058-15)		2012-09-27	0000-00-00	No	No	Current
33342-058-39	33342005839	9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK	9 blister pack	2012-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	2025-09-02	Human Prescription Drug Label	15
Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	2019-09-11	HUMAN PRESCRIPTION DRUG LABEL	3
Irbesartan and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	2017-01-25	HUMAN PRESCRIPTION DRUG LABEL	1