Home NDC 0187-0146 Vaseretic
Product NDC 0187-0146
11-digit product format 001870146
Labeler code 0187
Product ID 0187-0146_b97cbaf1-3abe-4f23-b2a0-4ff43f8bf5cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name enalapril maleate and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Bausch Health US, LLC
Application NDA019221
Marketing category NDA
Marketing start 1986-10-31
Substance ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
Active strength 10; 25 mg/1; mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE], 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 N019221-001 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 N019221-003 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Vaseretic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENALAPRIL MALEATE 10 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9O25354EPJ Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858828 Internal RxNorm lookup 858830 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0187-0146-01 Vaseretic 100 in 1 BOTTLE TABLET 100 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-0146 VASERETIC (ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE) TABLET [BAUSCH HEALTH US, LLC] 21 Current NDC, Legacy NDC, 1 package rows 20230427_bf3007e2-8fcc-48de-8fd5-55e95033d62f.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vaseretic ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Bausch Health US, LLC bf3007e2-8fcc-48de-8fd5-55e95033d62f 2020-08-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019221 application number: NDA019221 ndc (product): 0187-0146
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0187-0146-01 00187014601 100 TABLET in 1 BOTTLE (0187-0146-01) 100 tablet 1986-10-31 0000-00-00 No No Current