NDC 51672-4046-01 - Enalapril Maleate and Hydrochlorothiazide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 51672-4046
Requested NDC: 51672-4046-01
Package NDCs from labels: 51672-4046-1, 51672-4046-3, 51672-4046-01
Manufacturer: Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date: 2026-07-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Enalapril Maleate and Hydrochlorothiazide Tablets, USP	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries, Ltd.	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate and Hydrochlorothiazide Tablets, USP	NuCare Pharmaceuticals,Inc.	2021-02-12	HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate and Hydrochlorothiazide - Rebel Distributors Corp	Rebel Distributors Corp	2010-12-20	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-4046-1	Enalapril Maleate and Hydrochlorothiazide	100 in 1 BOTTLE	TABLET	100		12
51672-4046-3	Enalapril Maleate and Hydrochlorothiazide	1000 in 1 BOTTLE	TABLET	1000		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4046	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	12	Current NDC, Legacy NDC, 2 package rows	20240509_7cb92cf2-46f2-4379-937c-168d230e43a4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4046-1	EA - Each	51672-4046	0843b439-9694-412b-a9b3-6db98999e827	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Enalapril Maleate	ACTIVE INGREDIENT	9O25354EPJ	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
Hydrochlorothiazide	ACTIVE INGREDIENT	0J48LPH2TH	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
Enalaprilat Anhydrous	ACTIVE MOIETY	Q508Q118JM	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
Hydrochlorothiazide	ACTIVE MOIETY	0J48LPH2TH	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
Enalapril Maleate	ACTIVE INGREDIENT	9O25354EPJ	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
Hydrochlorothiazide	ACTIVE INGREDIENT	0J48LPH2TH	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
Enalapril	ACTIVE MOIETY	69PN84IO1A	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
Hydrochlorothiazide	ACTIVE MOIETY	0J48LPH2TH	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERROUS OXIDE	INACTIVE INGREDIENT	G7036X8B5H	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1

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 37 of 53 · 1,047 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Empathy	AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA	Deseret Biologicals, Inc.	a89067c1-ef12-49da-8fa6-e65ff664f497	2024-08-13	Warnings	Exact identifier unii: 059QF0KO0R
Omeprazole/Sodiium Bicarbonate	OMEPRAZOLE/SODIIUM BICARBONATE	Direct_rx	1f7f63c1-17c2-9a05-e063-6394a90abc6f	2024-08-12	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4c1a92c0-b491-4ae9-8bd0-029beb2b13c6	2024-08-12	Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	204592ba-a68f-452a-9987-1b33b7b6c4d5	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	be69f132-8b77-4590-a688-cb3709649466	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	cc58a6a5-5ccd-451c-837c-781d0a8da5cf	2024-08-05	Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b78ad43f-f132-4f03-8c85-2cf9b3ab555b	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	1e02787f-ccb5-abc2-e063-6294a90af7c3	2024-07-24	Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	4af326db-bf2d-5310-e054-00144ff88e88	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	7cc69c16-0dcc-874d-e053-2991aa0a9919	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	NuCare Pharmaceuticals,Inc.	af74c331-7402-408c-e053-2a95a90a1043	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	NuCare Pharmaceuticals,Inc.	b2e8b3bb-0ab5-ffd7-e053-2995a90aa2b6	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	NuCare Pharmaceuticals,Inc.	b4c9abf7-a2c6-7042-e053-2a95a90a7653	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Lisinopril and hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	NuCarePharmaceuticals, Inc.	4fbf31a1-037b-31a2-e054-00144ff88e88	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	7c214ebf-e0ed-6538-e053-2991aa0a8079	2024-07-16	Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	4925a3ad-63bd-108a-e054-00144ff8d46c	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	ddee28fb-c871-a6d4-984f-515522b28412	2024-07-15	Warnings	Exact identifier unii: 8MDF5V39QO
Thompson Safety Eyewash	WATER	Thompson Safety	1d0e96cf-245b-cfb7-e063-6294a90a4ced	2024-07-12	Warnings	Exact identifier unii: 059QF0KO0R
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	53fe1730-a803-26b2-e054-00144ff88e88	2024-07-09	Warnings, Adverse reactions	Exact identifier unii: 0J48LPH2TH
Enalapril maleate oral solution	ENALAPRIL MALEATE	Bionpharma Inc.	9391b8d8-2217-4838-8976-1a5ad90ef4ca	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9O25354EPJ

Reported adverse events (FAERS/openFDA)#

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