FDA.reportPublic FDA data

Indapamide

Product NDC
0378-0069
11-digit product format
003780069
Labeler code
0378
Product ID
0378-0069_a92c5cdc-8cb6-44ad-ae7d-d6f415f1e8c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indapamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074461
Marketing category
ANDA
Marketing start
1997-03-26
Marketing end
0000-00-00
Substance
INDAPAMIDE
Active strength
1 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bda0d04-c82b-7786-6ed9-2a416b849e7aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0069-01EA - Each0378-00690e7ab330-85f3-4e98-9423-54e5f2af43cc12012-07-24
0378-0069-05EA - Each0378-0069304adf17-d774-4560-935b-2e346f4c3e3712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDAPAMIDEACTIVE INGREDIENTF089I0511LINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
INDAPAMIDEACTIVE MOIETYF089I0511LINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
INDAPAMIDEACTIVE INGREDIENTF089I0511LINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
INDAPAMIDEACTIVE MOIETYF089I0511LINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197815indapamide 1.25 MG Oral TabletPSN55cf66a2-286d-44d8-8887-17a80939a66f2
197815indapamide 1.25 MG Oral TabletSCD55cf66a2-286d-44d8-8887-17a80939a66f2
197815indapamide 1.25 MG Oral TabletPSN92c7be7d-8c89-476a-b131-9deef76ed0161
197815indapamide 1.25 MG Oral TabletSCD92c7be7d-8c89-476a-b131-9deef76ed0161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0069-0100378006901100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0069-01) 1997-03-260000-00-00NoNoCurrent
0378-0069-0500378006905500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0069-05) 1997-03-260000-00-00NoNoCurrent