FDA.reportPublic FDA data

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product NDC
68788-8463
Requested package NDC
68788-8463-3
11-digit product format
687888463
Labeler code
68788
Product ID
68788-8463_0324b913-3ee4-4e08-94db-ef5201e4581a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206083
Marketing category
ANDA
Marketing start
2023-06-23
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
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALAB2016-02-08
A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALAB2016-02-08
A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALAB2016-02-08
A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALAB2016-02-08
A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALAB2016-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206083-001AB
A206083-002AB
A206083-003AB
A206083-004AB
A206083-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-0884e616aacf4f…
2026-09-14 22:38:342026-08A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-0884e616aacf4f…
2026-09-14 22:38:342026-08A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-0884e616aacf4f…
2026-09-14 22:38:342026-08A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-0884e616aacf4f…
2026-09-14 22:38:342026-08A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-0884e616aacf4f…
2026-08-18 06:07:402026-07A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2016-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2016-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2016-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2016-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2016-02-0803ed91905a0d…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206083-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206083-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206083-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206083-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A206083-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A206083-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206083-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206083-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206083-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206083-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206083-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206083-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206083-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206083-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206083-005AB103ed91905a0d…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN160 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80M03YXJ7IInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200285Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d09747f0-029e-4090-949b-e939948249b5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8463-3VALSARTAN AND HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET, FILM COATED303
68788-8463-6VALSARTAN AND HYDROCHLOROTHIAZIDE60 in 1 BOTTLETABLET, FILM COATED603
68788-8463-9VALSARTAN AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8463-3EA - Each68788-84634d8ff950-607d-4be6-82f5-4dc37171fe2612023-08-08
68788-8463-6EA - Each68788-846320c05c3c-2b21-4aa5-bb27-a7acb1b5a42412023-08-08
68788-8463-9EA - Each68788-8463d1a1d542-8ef7-4bb1-95d5-4d67052839f812023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8463VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20240830_d09747f0-029e-4090-949b-e939948249b5.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackaf46984c-cb58-4886-baa2-0ee075242c272026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.d09747f0-029e-4090-949b-e939948249b52025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
ndc (package): 68788-8463-3
ndc (product): 68788-8463
ndc11 (package): 68788846303
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLCf8b0a8ab-4549-4553-a127-bf2c0291a4b12025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf1df0d1e-d418-4f6e-a04a-77b5d4000e2b2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackd55b2f01-5cd1-40bb-8d36-34b5b9081ddc2025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46addda8-f798-4207-b8fb-ea75c5903a362025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions3f1321b2-cad7-47c7-863f-38aa7a8b35992024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions93833cf2-631b-4058-809d-16cc11b858c02024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsb6dc0544-898e-41e3-bd18-5757ede4477d2024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack38d84a2b-3c83-44a0-97d8-3f64d61017322023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions3131809e-885a-42d3-b6ad-1b208fd3ba562023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206083
application number: ANDA206083

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd09747f0-029e-4090-949b-e939948249b53
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDd09747f0-029e-4090-949b-e939948249b53
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYd09747f0-029e-4090-949b-e939948249b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8463-36878884630330 TABLET, FILM COATED in 1 BOTTLE (68788-8463-3) 2023-06-23NoNoCurrent