FDA.reportPublic FDA data

Indapamide

Product NDC
68788-7247
11-digit product format
687887247
Labeler code
68788
Product ID
68788-7247_821a8777-e8a6-4cac-9936-7ba9615ae44a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indapamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA074722
Marketing category
ANDA
Marketing start
2018-08-20
Substance
INDAPAMIDE
Active strength
2.5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Indapamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDAPAMIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF089I0511L
Rxcui197816

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7247-1Indapamide100 in 1 BOTTLETABLET, FILM COATED1009
68788-7247-3Indapamide30 in 1 BOTTLETABLET, FILM COATED309
68788-7247-6Indapamide60 in 1 BOTTLETABLET, FILM COATED609
68788-7247-9Indapamide90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7247-1EA - Each68788-72470689f1c3-fa87-454d-a1c4-33b1c0a8248e12018-11-06
68788-7247-3EA - Each68788-7247f0b46ebb-20ac-48e0-a21b-f31e2cb7b6e912018-11-06
68788-7247-6EA - Each68788-7247e431706f-70d8-42a0-88ff-eb8956cb2bed12018-11-06
68788-7247-9EA - Each68788-72477c3e1d94-2ce0-46cf-a216-5b3390cf741312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7247INDAPAMIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 4 package rows20240526_59cd3331-7afe-432a-8b50-39533fd5f392.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197816indapamide 2.5 MG Oral TabletPSN59cd3331-7afe-432a-8b50-39533fd5f3929
197816indapamide 2.5 MG Oral TabletSCD59cd3331-7afe-432a-8b50-39533fd5f3929
197816indapamide (as indapamide hemihydrate) 2.5 MG Oral TabletSY59cd3331-7afe-432a-8b50-39533fd5f3929

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7247-168788724701100 TABLET, FILM COATED in 1 BOTTLE (68788-7247-1) 2018-08-200000-00-00NoNoCurrent
68788-7247-36878872470330 TABLET, FILM COATED in 1 BOTTLE (68788-7247-3) 2018-08-200000-00-00NoNoCurrent
68788-7247-66878872470660 TABLET, FILM COATED in 1 BOTTLE (68788-7247-6) 2018-08-200000-00-00NoNoCurrent
68788-7247-96878872470990 TABLET, FILM COATED in 1 BOTTLE (68788-7247-9) 2018-08-200000-00-00NoNoCurrent