FDA.reportPublic FDA data

Lisinopril and Hydrochlorothiazide

Product NDC
76282-448
Requested package NDC
76282-448-01
11-digit product format
762820448
Labeler code
76282
Product ID
76282-448_7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA204058
Marketing category
ANDA
Marketing start
2019-05-01
Substance
HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength
25; 20 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;10MGTABLET / ORALAB2017-05-23
A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;20MGTABLET / ORALABRS2017-05-23
A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL25MG;20MGTABLET / ORALABRS2017-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204058-001AB
A204058-002AB
A204058-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204058-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALABRS2017-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204058-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALABRS2017-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204058-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2017-05-238072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204058-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204058-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204058-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204058-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204058-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204058-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204058-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204058-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204058-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204058-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204058-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204058-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204058-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204058-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204058-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204058-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204058-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204058-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204058-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204058-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204058-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204058-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204058-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204058-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204058-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204058-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204058-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204058-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204058-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204058-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204058-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204058-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204058-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204058-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204058-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204058-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204058-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204058-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204058-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204058-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL25 mg/1
HYDROCHLOROTHIAZIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E7199S1YWRInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197885Internal RxNorm lookup
197886Internal RxNorm lookup
197887Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c40b15ec-6083-4778-bca8-3e895e5694e1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
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
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
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
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
76282-448-012023-03-28Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-448-052023-03-28Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-448-102023-03-28Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-448-902023-03-28Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-448-012023-01-30Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-448-052023-01-30Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-448-102023-01-30Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-448-902023-01-30Lisinopril and Hydrochlorothiazide Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-448-01Lisinopril and Hydrochlorothiazide100 in 1 BOTTLETABLET1004
76282-448-05Lisinopril and Hydrochlorothiazide500 in 1 BOTTLETABLET5004
76282-448-10Lisinopril and Hydrochlorothiazide1000 in 1 BOTTLETABLET10004
76282-448-90Lisinopril and Hydrochlorothiazide90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-448-01EA - Each76282-44863cdec5d-469d-42a5-aaa1-186ebcc8b4d612019-09-05
76282-448-05EA - Each76282-44830a2b994-798e-44ed-88e8-bc213ea1228c12019-09-05
76282-448-10EA - Each76282-448cce778fe-0dfb-44f0-969e-5b82f745949612019-09-05
76282-448-90EA - Each76282-44863690197-d710-4ce7-abd9-f02d061031bd12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-448LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS) TABLET [EXELAN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 4 package rows20230329_c40b15ec-6083-4778-bca8-3e895e5694e1.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.af74c331-7402-408c-e053-2a95a90a10432024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.b2e8b3bb-0ab5-ffd7-e053-2995a90aa2b62024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.b4c9abf7-a2c6-7042-e053-2a95a90a76532024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepack02eb8f54-789e-4148-912b-601d23a7df4a2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions9a315f3e-4d70-4308-a842-0e4c647a44b22023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepack1990af86-e9ec-48b8-b354-8456d6d80e0a2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSExelan Pharmaceuticals, Inc.c40b15ec-6083-4778-bca8-3e895e5694e12023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
ndc (package): 76282-448-01
ndc (product): 76282-448
ndc11 (package): 76282044801
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSCipla USA Inc.40e6b627-63dc-4d52-aaa8-750663ad86c22021-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSAphena Pharma Solutions - Tennessee, LLCe2903227-4a79-4a9c-b96b-073b8e41fb012020-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204058
application number: ANDA204058

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc40b15ec-6083-4778-bca8-3e895e5694e14
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc40b15ec-6083-4778-bca8-3e895e5694e14
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNc40b15ec-6083-4778-bca8-3e895e5694e14
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCDc40b15ec-6083-4778-bca8-3e895e5694e14
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCDc40b15ec-6083-4778-bca8-3e895e5694e14
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCDc40b15ec-6083-4778-bca8-3e895e5694e14
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSYc40b15ec-6083-4778-bca8-3e895e5694e14
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSYc40b15ec-6083-4778-bca8-3e895e5694e14
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSYc40b15ec-6083-4778-bca8-3e895e5694e14
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe2903227-4a79-4a9c-b96b-073b8e41fb011
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe2903227-4a79-4a9c-b96b-073b8e41fb011
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe2903227-4a79-4a9c-b96b-073b8e41fb011
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCDe2903227-4a79-4a9c-b96b-073b8e41fb011
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCDe2903227-4a79-4a9c-b96b-073b8e41fb011
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCDe2903227-4a79-4a9c-b96b-073b8e41fb011
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSYe2903227-4a79-4a9c-b96b-073b8e41fb011
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSYe2903227-4a79-4a9c-b96b-073b8e41fb011
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSYe2903227-4a79-4a9c-b96b-073b8e41fb011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-448-0176282044801100 TABLET in 1 BOTTLE (76282-448-01) 100 tablet2019-05-010000-00-00NoNoCurrent