FDA.reportPublic FDA data

Amlodipine, Valsartan and Hydrochlorothiazide

Product NDC
68180-771
Requested package NDC
68180-771-02
11-digit product format
681800771
Labeler code
68180
Product ID
68180-771_5e938b33-b86d-40ab-b5c5-b7137ef9404d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine, Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA200797
Marketing category
ANDA
Marketing start
2015-06-04
Substance
AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
5; 160; 12.5 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 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
A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 5MG BASE;12.5MG;160MGTABLET / ORAL2015-06-03
A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 5MG BASE;25MG;160MGTABLET / ORAL2015-06-03
A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 10MG BASE;12.5MG;160MGTABLET / ORAL2015-06-03
A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 10MG BASE;25MG;160MGTABLET / ORAL2015-06-03
A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 10MG BASE;25MG;320MGTABLET / ORAL2015-06-03

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 22:38:342026-08A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORAL2015-06-0384e616aacf4f…
2026-09-14 22:38:342026-08A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORAL2015-06-0384e616aacf4f…
2026-09-14 22:38:342026-08A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORAL2015-06-0384e616aacf4f…
2026-09-14 22:38:342026-08A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORAL2015-06-0384e616aacf4f…
2026-09-14 22:38:342026-08A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORAL2015-06-0384e616aacf4f…
2026-08-18 06:07:402026-07A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORAL2015-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORAL2015-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORAL2015-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORAL2015-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORAL2015-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2015-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2015-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2015-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2015-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2015-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2015-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2015-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2015-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2015-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2015-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2015-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2015-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2015-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2015-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2015-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2015-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2015-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2015-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2015-06-0303ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200797-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200797-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200797-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200797-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200797-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200797-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200797-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200797-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200797-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200797-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200797-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200797-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200797-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200797-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200797-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200797-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200797-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200797-005AB15bbf6a4d5a75…

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
Amlodipine, Valsartan and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
VALSARTAN160 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864V2Q084HInternal UNII lookup
80M03YXJ7IInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
848131Internal RxNorm lookup
848135Internal RxNorm lookup
848140Internal RxNorm lookup
848145Internal RxNorm lookup
848151Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5dbb43b1-3ea4-4fa5-a9aa-95d869ae65feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
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
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product 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
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product 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
68180-771-02Amlodipine, Valsartan and Hydrochlorothiazide500 in 1 BOTTLETABLET, FILM COATED50011
68180-771-06Amlodipine, Valsartan and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3011
68180-771-09Amlodipine, Valsartan and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-771-06EA - Each68180-771d19f50db-a24b-4eea-a4d4-825ac30d420d12015-07-20
68180-771-09EA - Each68180-7716c0b8e82-eda2-4266-be4d-801f5bb109ec12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
VALSARTANACTIVE INGREDIENT80M03YXJ7IAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
VALSARTANACTIVE MOIETY80M03YXJ7IAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-771AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 3 package rows20231215_5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200797
application number: ANDA200797
ndc (package): 68180-771-02
ndc (product): 68180-771
ndc11 (package): 68180077102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848131amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848151amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848135amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848140amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848145amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848131amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848151amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848135amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCD5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848140amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848145amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848131amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848135amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848151amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848140amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848145amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848131amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848151amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848135amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848140amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11
848145amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSY5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-771-0268180077102500 TABLET, FILM COATED in 1 BOTTLE (68180-771-02) 2015-06-040000-00-00NoNoCurrent