VALSARTAN AND HYDROCHLOROTHIAZIDE

Product NDC: 43547-312
Requested package NDC: 43547-312-03
11-digit product format: 435470312
Labeler code: 43547
Product ID: 43547-312_2d03a607-2ffd-4df1-8c94-bec2b786709c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA206083
Marketing category: ANDA
Marketing start: 2015-10-31
Substance: VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength: 160; 12.5 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08
A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08
A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08
A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	AB	2016-02-08
A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	AB	2016-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206083-001	AB
A206083-002	AB
A206083-003	AB
A206083-004	AB
A206083-005	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 · 215 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
2026-09-14 22:38:34	2026-08	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206083-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206083-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: VALSARTAN AND HYDROCHLOROTHIAZIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALSARTAN	160 mg/1
HYDROCHLOROTHIAZIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
80M03YXJ7I	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200284	Internal RxNorm lookup
200285	Internal RxNorm lookup
349353	Internal RxNorm lookup
636042	Internal RxNorm lookup
636045	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
f8b0a8ab-4549-4553-a127-bf2c0291a4b1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
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
e7dfdaab-7cf9-4f89-804c-eff5108d94d1	Product name	9	20250305
b6abae2f-ee27-47bc-b150-54dc8d969483	Product name	2	20250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
89dac932-b90a-4410-9ab1-84c53e57de25	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
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43547-312-03	VALSARTAN AND HYDROCHLOROTHIAZIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	23
43547-312-09	VALSARTAN AND HYDROCHLOROTHIAZIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	23
43547-312-50	VALSARTAN AND HYDROCHLOROTHIAZIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-312-09	EA - Each	43547-312	d0d6b098-f1e7-4e4b-9751-25b4af3a6e9a	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-312	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	22	Current NDC, Legacy NDC, 3 package rows	20230619_f8b0a8ab-4549-4553-a127-bf2c0291a4b1.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	af46984c-cb58-4886-baa2-0ee075242c27	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	d09747f0-029e-4090-949b-e939948249b5	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083 ndc (package): 43547-312-03 ndc (product): 43547-312 ndc11 (package): 43547031203
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f1df0d1e-d418-4f6e-a04a-77b5d4000e2b	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	d55b2f01-5cd1-40bb-8d36-34b5b9081ddc	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	46addda8-f798-4207-b8fb-ea75c5903a36	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	3f1321b2-cad7-47c7-863f-38aa7a8b3599	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	93833cf2-631b-4058-809d-16cc11b858c0	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b6dc0544-898e-41e3-bd18-5757ede4477d	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	38d84a2b-3c83-44a0-97d8-3f64d6101732	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	3131809e-885a-42d3-b6ad-1b208fd3ba56	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	PSN	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
200285	valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
349353	valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
636042	valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
636045	valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
200285	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
636042	hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet	SCD	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
200284	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet	SCD	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
349353	hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
636045	hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
200285	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
636042	HCTZ 12.5 MG / valsartan 320 MG Oral Tablet	SY	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	SY	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
349353	HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
636045	HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	23
200285	valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	d09747f0-029e-4090-949b-e939948249b5	3
200285	valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	3131809e-885a-42d3-b6ad-1b208fd3ba56	3
200285	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	d09747f0-029e-4090-949b-e939948249b5	3
200285	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	3131809e-885a-42d3-b6ad-1b208fd3ba56	3
200285	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	d09747f0-029e-4090-949b-e939948249b5	3
200285	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	3131809e-885a-42d3-b6ad-1b208fd3ba56	3
200285	valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	d55b2f01-5cd1-40bb-8d36-34b5b9081ddc	1
200285	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	d55b2f01-5cd1-40bb-8d36-34b5b9081ddc	1
200285	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	d55b2f01-5cd1-40bb-8d36-34b5b9081ddc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-312-03	43547031203	30 TABLET, FILM COATED in 1 BOTTLE (43547-312-03)	2021-12-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VALSARTAN AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	3
VALSARTAN AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC \| Prinston Pharmaceutical Inc. \| Zhejiang Huahai Pharmaceutical Co., LTD \| Zhejiang Huahai Pharmaceutical Technology Co., LTD	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	23
VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	2025-05-29	HUMAN PRESCRIPTION DRUG LABEL	1
VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	3
VALSARTAN AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	1