Fosinopril Sodium and Hydrochlorothiazide

Product NDC
65862-308
11-digit product format
658620308
Labeler code
65862
Product ID
65862-308_34bf0456-37d0-4d7d-a585-1555b7bc9373
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril Sodium and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079245
Marketing category
ANDA
Marketing start
2009-07-09
Substance
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Active strength
10; 12.5 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSINOPRIL SODIUM10 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, NW2RTH6T2N
Rxcui857166, 857174

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
90aa3f6a-97f0-be7e-d25b-b26d56ae287eProduct name320201015
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-308-01Fosinopril Sodium and Hydrochlorothiazide100 in 1 BOTTLETABLET10012
65862-308-30Fosinopril Sodium and Hydrochlorothiazide30 in 1 BOTTLETABLET3012
65862-308-99Fosinopril Sodium and Hydrochlorothiazide1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-308-01EA - Each65862-30836a1526f-de03-47ef-908a-de1652b474bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSINOPRIL SODIUMACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
FOSINOPRILATACTIVE MOIETYS312EY6ZT8FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-308FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 3 package rows20240430_35019655-9a30-4305-a262-936ad0e73071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857166fosinopril sodium 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN35019655-9a30-4305-a262-936ad0e7307112
857174fosinopril sodium 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN35019655-9a30-4305-a262-936ad0e7307112
857166fosinopril sodium 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD35019655-9a30-4305-a262-936ad0e7307112
857174fosinopril sodium 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD35019655-9a30-4305-a262-936ad0e7307112
857166FNP Sodium 10 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112
857174FNP Sodium 20 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112
857166fosinopril sodium 10 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112
857174fosinopril sodium 20 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-308-0165862030801100 TABLET in 1 BOTTLE (65862-308-01) 100 tablet2009-07-090000-00-00NoNoCurrent
65862-308-306586203083030 TABLET in 1 BOTTLE (65862-308-30) 30 tablet2009-07-090000-00-00NoNoCurrent
65862-308-99658620308991000 TABLET in 1 BOTTLE (65862-308-99) 1000 tablet2009-07-090000-00-00NoNoCurrent